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2.0 - 7.0 years
4 - 9 Lacs
Aurangabad
Work from Office
" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL s full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization. Scope of the role Scope - This role is responsible for Responsibilities Achievement of set targets. Maintaining set call Average/coverage. Complete use of allotted resources. Increasing prescriber base Focus on target customers. Maintaining call average and customer coverage Increasing PCPM. Timely reporting. Ensuring ROI Relationships around the role Reporting to (Business) Regional Sales Manager / Sr. Regional Sales Manager Reporting to (Matrix) NA No of Reportees Direct NA Indirect NA Key External Stakeholder(s) Doctors, Stockiest, Retailers, CFA staff, Fellow professionals, institutional administrators Key Internal Stakeholder(s) RSM, ZSM, BDM, NSM / SM, PMT, HR & Sales Admin Competencies critical for the role Scientific/ Technical Competencies Proficiency level Convincing ability Presentation Selling Communication Behavioral Analytical ability PR Skills Academic qualifications and experience required for the role Required Educational Qualification & Relevant experience Desirable - B.Pharm / D.Pharm / BSc. + MBA Essential - Graduates in any discipline Experience: 6 Months. to 2 years as a Medical Rep in a reputed organization. Age should be around 28 years ",
Posted 1 month ago
2.0 - 7.0 years
4 - 9 Lacs
Ahmedabad
Work from Office
" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL s full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization. Scope of the role Scope - This role is responsible for Responsibilities Achievement of set targets. Maintaining set call Average/coverage. Complete use of allotted resources. Increasing prescriber base Focus on target customers. Maintaining call average and customer coverage Increasing PCPM. Timely reporting. Ensuring ROI Relationships around the role Reporting to (Business) Regional Sales Manager / Sr. Regional Sales Manager Reporting to (Matrix) NA No of Reportees Direct NA Indirect NA Key External Stakeholder(s) Doctors, Stockiest, Retailers, CFA staff, Fellow professionals, institutional administrators Key Internal Stakeholder(s) RSM, ZSM, BDM, NSM / SM, PMT, HR & Sales Admin Competencies critical for the role Scientific/ Technical Competencies Proficiency level Convincing ability Presentation Selling Communication Behavioral Analytical ability PR Skills Academic qualifications and experience required for the role Required Educational Qualification & Relevant experience Desirable - B.Pharm / D.Pharm / BSc. + MBA Essential - Graduates in any discipline Experience: 6 Months. to 2 years as a Medical Rep in a reputed organization. Age should be around 28 years ",
Posted 1 month ago
2.0 - 7.0 years
4 - 9 Lacs
Ahmedabad
Work from Office
" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL s full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization. Scope of the role Scope - This role is responsible for Responsibilities Supervision & Control Managing Team Brand growth Prescription Growth Prescribers growth Market Share Ensuring ROI Development of subordinates Relationships around the role Reporting to (Business) Zonal Sales Manager Reporting to (Matrix) NA No of Reportees Direct 4-5 Indirect NA Key External Stakeholder(s) Doctors, Stockiest, Retailers, CFA staff, Fellow professionals, Institutional administrators Key Internal Stakeholder(s) Superiors, Subordinates , PMT, HR & Sales Admin Competencies critical for the role Scientific/ Technical Competencies Proficiency level Proven Leadership qualities Good communicator Proven track records Ambitious Behavioral Analytical ability
Posted 2 months ago
5.0 - 8.0 years
5 - 10 Lacs
Navi Mumbai, Mumbai (All Areas)
Work from Office
KRA's: Quality check of all raw materials, in-process and finished goods on a FIFO basis QMS Implementation Audit Documentation Internal/ external as well as 3rd party/ regulatory audit compliances Required Candidate profile 5+ years of experience in Quality [quality inspection, auditing, testing, reporting] in a medical device/ pharmaceutical manufacturing co. Should be ready to travel or relocate to Taloja Navi Mumbai
Posted 2 months ago
10.0 - 15.0 years
8 - 12 Lacs
Mumbai, Thane, Navi Mumbai
Work from Office
QMS Implementation Audit facilitation: will represent the company during regulatory/ 3rd party audits: MHRA, USFDA, MCC, WHO, etc. Products: temperature-controlled packaging & temperature monitoring systems used for storage & transit of medicines Required Candidate profile Any science graduates 10-15 years' experience in quality, ideally in pharma/ medical devices/ equipment manufacturing industry International Audit Experience mandatory Should be open for global travel
Posted 2 months ago
5.0 - 10.0 years
6 - 9 Lacs
Hyderabad, Medchal
Work from Office
KRA's: Ensure SOPs are followed & quality standards are met Quality check of raw materials, in-process & finished goods on a FIFO basis QMS Implementation Audit Documentation Audit facilitation - Internal/ external & 3rd party/ regulatory audits Required Candidate profile 5+ years of experience in Quality [quality inspection, auditing, testing, reporting] in a pharma/ medical device mfg. co Ready to relocate to Medchal, Hyderabad Accommodation & food will be provided Perks and benefits Accommodation and Food provided
Posted 2 months ago
2.0 - 7.0 years
4 - 9 Lacs
Kanpur
Work from Office
" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL s full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization. Scope of the role Scope - This role is responsible for Responsibilities Achievement of set targets. Maintaining set call Average/coverage. Complete use of allotted resources. Increasing prescriber base Focus on target customers. Maintaining call average and customer coverage Increasing PCPM. Timely reporting. Ensuring ROI Relationships around the role Reporting to (Business) Regional Sales Manager / Sr. Regional Sales Manager Reporting to (Matrix) NA No of Reportees Direct NA Indirect NA Key External Stakeholder(s) Doctors, Stockiest, Retailers, CFA staff, Fellow professionals, institutional administrators Key Internal Stakeholder(s) RSM, ZSM, BDM, NSM / SM, PMT, HR & Sales Admin Competencies critical for the role Scientific/ Technical Competencies Proficiency level Convincing ability Presentation Selling Communication Behavioral Analytical ability PR Skills Academic qualifications and experience required for the role Required Educational Qualification & Relevant experience Desirable - B.Pharm / D.Pharm / BSc. + MBA Essential - Graduates in any discipline Experience: 6 Months. to 2 years as a Medical Rep in a reputed organization. Age should be around 28 years ",
Posted 2 months ago
5.0 - 7.0 years
7 - 9 Lacs
Kolkata
Work from Office
" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL s full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization. Scope of the role Scope - This role is responsible for Responsibilities Supervision & Control Managing Team Brand growth Prescription Growth Prescribers growth Market Share Ensuring ROI Development of subordinates Relationships around the role Reporting to (Business) Zonal Sales Manager Reporting to (Matrix) NA No of Reportees Direct 4-5 Indirect NA Key External Stakeholder(s) Doctors, Stockiest, Retailers, CFA staff, Fellow professionals, Institutional administrators Key Internal Stakeholder(s) Superiors, Subordinates , PMT, HR & Sales Admin Competencies critical for the role Scientific/ Technical Competencies Proficiency level Proven Leadership qualities Good communicator Proven track records Ambitious Behavioral Analytical ability PR Skills Dependable Contributor Good Products knowledge Creative & Assertive Academic qualifications and experience required for the role Required Educational Qualification & Relevant experience Desirable - B.Pharm / D.Pharm / BSc. + MBA Essential - Graduates in any discipline Experience : 5 to 7 years of Total experience and 1 2 years of First Line experience Age should be around 32 years ",
Posted 2 months ago
2.0 - 7.0 years
4 - 9 Lacs
Kolkata
Work from Office
Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL s full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer for more information about organization. Scope of the role Scope - This role is responsible for Responsibilities Supervision & Control Managing Team Brand growth Prescription Growth Prescribers growth Market Share Ensuring ROI Development of subordinates Relationships around the role Reporting to (Business) Zonal Sales Manager Reporting to (Matrix) NA No of Reportees Direct 4-5 Indirect NA Key External Stakeholder(s) Doctors, Stockiest, Retailers, CFA staff, Fellow professionals, Institutional administrators Key Internal Stakeholder(s) Superiors, Subordinates , PMT, HR & Sales Admin Competencies critical for the role Scientific/ Technical Competencies Proficiency level Proven Leadership qualities Good communicator Proven track records Ambitious Behavioral Analytical ability PR Skills Dependable Contributor Good Products knowledge Creative & Assertive Academic qualifications and experience required for the role Required Educational Qualification & Relevant experience Desirable - B.Pharm / D.Pharm / BSc. + MBA Essential - Graduates in any discipline Experience : 5 to 7 years of Total experience and 1 2 years of First Line experience Age should be around 32 years
Posted 2 months ago
2.0 - 7.0 years
4 - 9 Lacs
Kanpur
Work from Office
Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL s full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer for more information about organization. Scope of the role Scope - This role is responsible for Responsibilities Achievement of set targets. Maintaining set call Average/coverage. Complete use of allotted resources. Increasing prescriber base Focus on target customers. Maintaining call average and customer coverage Increasing PCPM. Timely reporting. Ensuring ROI Relationships around the role Reporting to (Business) Regional Sales Manager / Sr. Regional Sales Manager Reporting to (Matrix) NA No of Reportees Direct NA Indirect NA Key External Stakeholder(s) Doctors, Stockiest, Retailers, CFA staff, Fellow professionals, institutional administrators Key Internal Stakeholder(s) RSM, ZSM, BDM, NSM / SM, PMT, HR & Sales Admin Competencies critical for the role Scientific/ Technical Competencies Proficiency level Convincing ability Presentation Selling Communication Behavioral Analytical ability PR Skills Academic qualifications and experience required for the role Required Educational Qualification & Relevant experience Desirable - B.Pharm / D.Pharm / BSc. + MBA Essential - Graduates in any discipline Experience: 6 Months. to 2 years as a Medical Rep in a reputed organization. Age should be around 28 years
Posted 2 months ago
14.0 - 16.0 years
8 - 9 Lacs
Bharuch
Work from Office
Quality professional with 1 5 .0 + years of progressive experience with strong knowledge of Speciality Ingredient, Bulk Chemicals, Food additive/ Food supplement & API Manufacturing, QMS, Qualification, Validation and other Manufacturing functions. Personnel shall have experience to handle certification, customer & regulatory inspection i.e.: IMS, WHO-GMP, FSSC, FAMI-QS, EnMS , Halal, Kosher & Responsible Care & regulatory (FDCA, USFDA, MHRA). Expertise in change control, deviation, market complaint, non-conformance investigation, vendor audit, self-inspection, gap assessment, customer audit, training, vendor management, vendor questionnaire, validation, equipment & utility system qualification & digitization Def The Person Qualifications & Experience: - M.Sc - Chemistry 15+ years of exp. Industry experience Personal Characteristics: - Ability to work in a matrix organization. An excellent people manager and leader; able to recruit, develop and retain a high calibre team across diverse departments. Able to work effectively within a global business culture whilst also adaptable to the local cultural environment. Ability to energise his/her team with a clear vision of the business Excellent communication and negotiation skills Should have an entrepreneurial mind-set Strong negotiation and analytical skills
Posted 2 months ago
0.0 - 5.0 years
8 - 9 Lacs
Bharuch
Work from Office
The Position Organization : - Jubilant Ingrevia Limited Designation / Position: - Dy Manager QA Band / Grade / Level: - L2 Location : - Bharuch Job Summary (Optional): - Reporting Manager: - Sr. Manager -QA Direct Reports (Optional): - Nil Team Size (Optional): - 10 Matrix Relationship (Optional): - Key Responsibilities Quality professional with 15.0+ years of progressive experience with strong knowledge of Speciality Ingredient, Bulk Chemicals, Food additive/ Food supplement & API Manufacturing, QMS, Qualification, Validation and other Manufacturing functions. Personnel shall have experience to handle certification, customer & regulatory inspection i.e.: IMS, WHO-GMP, FSSC, FAMI-QS, EnMS, Halal, Kosher & Responsible Care & regulatory (FDCA, USFDA, MHRA). Expertise in change control, deviation, market complaint, non-conformance investigation, vendor audit, self-inspection, gap assessment, customer audit, training, vendor management, vendor questionnaire, validation, equipment & utility system qualification & digitizationDef The Person Qualifications & Experience: - M.Sc- Chemistry 15+ years of exp. Industry experience Personal Characteristics: - Ability to work in a matrix organization. An excellent people manager and leader; able to recruit, develop and retain a high calibre team across diverse departments. Able to work effectively within a global business culture whilst also adaptable to the local cultural environment. Ability to energise his/her team with a clear vision of the business Excellent communication and negotiation skills Should have an entrepreneurial mind-set Strong negotiation and analytical skills
Posted 2 months ago
1.0 - 5.0 years
9 - 13 Lacs
Pune
Work from Office
As a global leader in cybersecurity, CrowdStrike protects the people, processes and technologies that drive modern organizations Since 2011, our mission hasnt changed "” were here to stop breaches, and weve redefined modern security with the worlds most advanced AI-native platform Our customers span all industries, and they count on CrowdStrike to keep their businesses running, their communities safe and their lives moving forward Were also a mission-driven company We cultivate a culture that gives every CrowdStriker both the flexibility and autonomy to own their careers Were always looking to add talented CrowdStrikers to the team who have limitless passion, a relentless focus on innovation and a fanatical commitment to our customers, our community and each other Ready to join a mission that mattersThe future of cybersecurity starts with you. About The Role CrowdStrike is looking for Analyst- Global Payroll as our payroll team is expanding This position is designed for a strong team contributor, analytically strong, numbers driven, detail-oriented Payroll leader to support our International Payroll team in our SSC-Pune, India. A strong team player and willing to go extra mile to ensure our Global payrolls/Projects are delivered timely with highest accuracy This is a fast-paced, dynamic role and you will take on interesting and challenging responsibilities as our organization continues to grow in both size and complexity This role will be a key part of the successful growth of the payroll team and located in our office in Pune, India. What You'll Do Payroll Management: Gather information required to perform payroll calculation. Calculate base salary, allowances and other components of payroll in accordance with organizational policies and procedures. Input data into payroll systems to support processing and calculating activities. Process routine payroll and related administration reports. Quality Management Review performance of software or hardware products or service components. Perform audits under stipulated conditions and highlight major incidents. Inspect Key deliverables/collaterals through toll gates. Ensure 100% compliance to internal processes and standards. Operational / Process Excellence Review current processes and report anomalies at a regular interval. Document and present feedback received through different channels. Suggest changes in input or output metrices for a process. Maintain trackers for all processes and draw actionable insights from the data. Governance & Compliance Follow legislation, policies, procedures, guidelines relevant to day-to-day operations as outlined by corporate governance policies. Vendor Management Connect with vendor monthly to discuss the ongoing issues and plan payrolls. Stakeholders Management Identify key stakeholders and the organization's relationship with them. Identify stakeholder needs, positions, and interests. Coordinate basic activities/and processes with stakeholders on a day-to-day basis. Apply knowledge of the Organization's position to respond to simple and complex queries from stakeholders. What Youll Need Bachelors Degree and or equivalent degree Minimum 3-5 years of experience with EMEA/APAC with a high-growth, fast paced environment Strong understanding of payroll systems, payroll statutory, earnings and deduction codes, GL mapping. Knowledge of ESPP, STOCK, RSU is a plus. Ability to handle multiple country payrolls and be proactive in a fast-paced environment with changing priorities. Ability to effectively communicate and provide a high level of service to internal and external customers, including all levels within the company. Individuals must be organized, analytical, and detail oriented. Experience with the following systems is preferredWorkday, NetSuite, SQL/SAP based payroll system. Work Location Kharadi, Pune (Work from Office) Shift Timing2:00 PM to 11:00 PM IST Benefits Of Working At CrowdStrike Remote-friendly and flexible work culture Market leader in compensation and equity awards Comprehensive physical and mental wellness programs Competitive vacation and holidays for recharge Paid parental and adoption leaves Professional development opportunities for all employees regardless of level or role s, geographic neighbourhood groups and volunteer opportunities to build connections Vibrant office culture with world class amenities Great Place to Work Certified„¢ across the globe CrowdStrike is proud to be an equal opportunity employer We are committed to fostering a culture of belonging where everyone is valued for who they are and empowered to succeed We support veterans and individuals with disabilities through our affirmative action program. CrowdStrike is committed to providing equal employment opportunity for all employees and applicants for employment The Company does not discriminate in employment opportunities or practices on the basis of race, color, creed, ethnicity, religion, sex (including pregnancy or pregnancy-related medical conditions), sexual orientation, gender identity, marital or family status, veteran status, age, national origin, ancestry, physical disability (including HIV and AIDS), mental disability, medical condition, genetic information, membership or activity in a local human rights commission, status with regard to public assistance, or any other characteristic protected by law We base all employment decisions--including recruitment, selection, training, compensation, benefits, discipline, promotions, transfers, lay-offs, return from lay-off, terminations and social/recreational programs--on valid job requirements. If you need assistance accessing or reviewing the information on this website or need help submitting an application for employment or requesting an accommodation, please contact us at recruiting@crowdstrike.com for further assistance. Show more Show less
Posted 2 months ago
20.0 - 25.0 years
10 - 20 Lacs
Ahmedabad, Gurugram
Work from Office
Guide the upgrade and development of plant infrastructure and systems to meet the requirements of: WHO-GMP, Russia, Australia/New Zealand, and African regulatory authorities, Ultimately UKMHRA and USFDA. Provide expert support on: WHO-GMP and GLP.
Posted 2 months ago
2.0 - 7.0 years
4 - 9 Lacs
Mumbai
Work from Office
Responsibilities Supervision & Control Managing Team Brand growth Prescription Growth Prescribers growth Market Share Ensuring ROI Development of subordinates Competencies critical for the role Scientific/ Technical Competencies Proficiency level Proven Leadership qualities Good communicator Proven track records Ambitious Behavioral Analytical ability
Posted 2 months ago
2.0 - 7.0 years
6 - 10 Lacs
Ahmedabad
Work from Office
Create and manage Quality Control (QC) master data in the Laboratory Information Management System (LIMS), including product specifications, test methods, and sampling plans. Ensure the accuracy, completeness, and compliance of master data with regulatory requirements and internal SOPs. Perform self-review and coordinate for Level 2 review and approval. Collaborate with QC, QA, IT, and other relevant departments to gather required documents and inputs for master creation and updates. Manage master data changes in line with approved change controls, ensuring timely and compliant updates. Troubleshoot and resolve data-related issues in LIMS, coordinating with IT or vendors when required. Maintain up-to-date documentation of master data changes and support audits by providing necessary LIMS records. Ensure all activities adhere to GMP, regulatory guidelines (like USFDA, MHRA, WHO), and internal quality standards.
Posted 2 months ago
5.0 - 10.0 years
12 - 16 Lacs
Gurugram
Work from Office
To Manage Regulatory Affairs for in compliance to applicable regulations and guidelines. This position will assist with the review of clinical/Biopharmaceutical/Non Clinical and labelling documentation, preparation and review of non-CMC sections, Variations, site transfers and post approval gap analysis. This position will also provide support of the regulatory function through document management, electronic submission compilation and management, and other group management activities as required. Position will be required to work with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Research and Development groups of the client organization of DDReg. Duties and responsibilities Providing high-quality Clinical, Biopharmaceutical, Pharmacokinetic, non-clinical review of CTD sections for regulatory filings to SRA (e.g EMA, UK MHRA, National Agencies of EU Member states, Canada, Australia) as well as agencies of ROW markets for DDReg clients Actively contribute to the development and implementation of regulatory strategies, processes and timelines for global approval. Carrying out Gap Analysis of Non-CMC sections for small molecules and biopharmaceuticals Authoring, and compiling CTDs sections, Variations (Major/Minor/Site Transfers) filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met. Prepare &/or review labelling documentation, managing labelling changes, prepare variation application on labelling changes, intended for submission to the above-mentioned agencies, internal consistency, for consistency to relevant guidelines and to promote regulatory excellence. Demonstrate subject matter and area expertise. Collaborate with internal and external clients. Supporting and enabling effective and efficient communication that results in operational excellence. Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices. Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on agencies website. Monitor competitive regulatory practices and actively review internal and external factors to mitigate potential problems. Ensure that draft labeling complies with all applicable regulations and guidelines Education & Experience Bachelor s or Master s degree in Pharma Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years ) or equivalent combination of education, training, & experience. Experience working in the pharmaceutical/CRO industry preferred Knowledge, Skills and Abilities Excellent technical data interpretation skills Strong project management skills Excellent interpersonal skills including problem solving Excellent oral and written communication skills with strong presentation skills Significant knowledge of global, regional, national and other document development guidelines In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc. Great judgment and decision-making skills Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook) Ability and desire to work in a team-oriented environment. Excellent written and verbal communication skills Highly proficient with Microsoft Word, PowerPoint and Excel. Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner Possesses a collaborative, results-driven style. Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines
Posted 2 months ago
6.0 - 11.0 years
7 - 8 Lacs
Gurugram
Work from Office
Assistant Manager Regulatory Affairs - EU - DDReg pharma Job Title: Assistant Manager Regulatory Affairs (EU & UK) Location: Gurgaon, Haryana (India) Experience: 4 6 Years Qualification: Master s Degree in Pharmacy (M.Pharm or equivalent) Role Overview We are seeking a proactive and detail-oriented Assistant Manager Regulatory Affairs to join our Global Regulatory team. The ideal candidate will be responsible for driving CMC documentation, regulatory submissions, and lifecycle management for the EU & UK markets , ensuring compliance with regional and international guidelines. Key Responsibilities Conduct comprehensive CMC reviews of technical documentation for regulatory filings across the EU and UK markets . Perform Gap Analysis and Remediation for Module 3 (CMC) sections to ensure submission readiness and alignment with regulatory standards. Develop and implement regulatory strategies, processes, and timelines for the preparation and submission of Marketing Authorization (MA) applications . Prepare and compile new CTD dossiers , variations , and renewals ensuring full compliance with applicable EMA/MHRA regulatory requirements and internal quality standards. Critically review documentation to ensure internal consistency , compliance with regulatory expectations, and support regulatory excellence . Collaborate with cross-functional teams including R&D, QA, QC, Manufacturing, and external stakeholders for timely and accurate data collation and submissions. Ensure effective and efficient communication across teams to facilitate streamlined project execution and meet submission timelines. Maintain high-level knowledge of current country-specific regulations , keeping track of regulatory updates through respective health authority websites (e.g., EMA, MHRA). Education & Experience Master s degree in Pharmacy or equivalent qualification. 4 to 6 years of relevant experience in Regulatory Affairs, with a focus on EU and/or UK submissions. Equivalent combinations of education, training, and practical experience may also be considered. Key Skills & Competencies Strong technical skills in data analysis and interpretation of regulatory documentation. Excellent interpersonal and problem-solving skills with a proactive and solution-oriented approach. Effective negotiation and communication skills for liaising with internal teams and external agencies. Proficient in drafting and reviewing documents in line with global, regional, and national regulatory standards. Expertise in document management systems and tools like Excel, Outlook, PowerPoint, and Word . Strong presentation and reporting skills with the ability to explain complex regulatory concepts clearly. Demonstrated ability to analyze data systematically , apply regulatory logic, and compile well-organized submissions. Collaborative, results-driven , and self-motivated with the flexibility to adapt to shifting priorities. Capable of delivering high-quality outputs under pressure and within aggressive timelines. Other Requirements Flexibility to work in cross-time-zone schedules , as needed to support global project coordination or agency interactions. Why Join Us? Be part of a high-performing regulatory team that plays a critical role in bringing impactful pharmaceutical products to patients globally. Work in a collaborative, fast-paced environment where your expertise shapes international market access strategies. Apply Online First Name Last Name A valid email address is required. United States United Kingdom Albania (Shqip ri) American Samoa Antigua and Barbuda Austria ( sterreich) Azerbaijan (Az rbaycan) Belgium (Belgi ) Benin (B nin) Bosnia and Herzegovina ( ) Brazil (Brasil) British Indian Ocean Territory British Virgin Islands Burkina Faso Burundi (Uburundi) Cameroon (Cameroun) Cape Verde (Kabu Verdi) Caribbean Netherlands Cayman Islands Central African Republic (R publique centrafricaine) Chad (Tchad) Christmas Island Cocos (Keeling) Islands Congo (DRC) (Jamhuri ya Kidemokrasia ya Kongo) Congo (Republic) (Congo-Brazzaville) Cook Islands Costa Rica C te d Ivoire Croatia (Hrvatska) Cura ao Czech Republic ( esk republika) Denmark (Danmark) Dominican Republic (Rep blica Dominicana) El Salvador Equatorial Guinea (Guinea Ecuatorial) Estonia (Eesti) Falkland Islands (Islas Malvinas) Faroe Islands (F royar) Finland (Suomi) French Guiana (Guyane fran aise) French Polynesia (Polyn sie fran aise) Germany (Deutschland) Ghana (Gaana) Greenland (Kalaallit Nunaat) Guinea (Guin e) Guinea-Bissau (Guin Bissau) Hong Kong ( ) Hungary (Magyarorsz g) Iceland ( sland) Isle of Man Italy (Italia) Latvia (Latvija) Lithuania (Lietuva) Macedonia (FYROM) ( ) Madagascar (Madagasikara) Marshall Islands Mauritius (Moris) Mexico (M xico) Moldova (Republica Moldova) Montenegro (Crna Gora) Mozambique (Mo ambique) Myanmar (Burma) ( ) Namibia (Namibi ) Netherlands (Nederland) New Caledonia (Nouvelle-Cal donie) New Zealand Niger (Nijar) Norfolk Island North Korea ( ) Northern Mariana Islands Norway (Norge) Panama (Panam ) Papua New Guinea Peru (Per ) Poland (Polska) Puerto Rico R union (La R union) Romania (Rom nia) Saint Barth lemy Saint Helena Saint Kitts and Nevis Saint Lucia Saint Martin (Saint-Martin (partie fran aise)) Saint Pierre and Miquelon (Saint-Pierre-et-Miquelon) +508 Saint Vincent and the Grenadines San Marino S o Tom and Pr ncipe (S o Tom e Pr ncipe)
Posted 2 months ago
1.0 - 5.0 years
11 - 15 Lacs
Hyderabad
Work from Office
Job Area: Finance & Accounting Group, Finance & Accounting Group > Global Accounting Ops Center General Summary: Company: Job Overview: As a Project Manager, you will play a key role in coordinating with partners and stakeholders to ensure the successful delivery of critical business projects. Project Managers will navigate barriers and work closely with functional team members to guide each project to completion. This role requires cross-functional collaboration and impeccable organization skills to deliver projects in a timely manner and within budget. Minimum Qualifications: Bachelor's degree 5+ years of Project Management-relevant work experience in Finance 2+ years of managing operating budgets and/or project financials. 2+ years of work experience in a role requiring interaction with senior leadership (e.g., Director level and above). 2+ years of work experience in change management PMO, PMP, Agile Methodology or Six Sigma Project Management Certification. Principal Roles and responsibilities Gathers stakeholder needs and goals with guidance and executes communication plan for project team and stakeholders. Forms project team, and manages and prioritizes the work of the project team by establishing schedules and task assignments, and tracking tasks of team members. Creates project goals and prioritizes deliverables with guidance from project stakeholders. Create roadmap and plan for change management, assess change impact. Apply a structured methodology and lead change management activities, support communication efforts, Manages multiple projects of small to medium size or complexity and applies up-to-date project management knowledge to meet deadlines. Builds and execute project plans for small- to medium-sized projects which include schedule and resource forecasting, stakeholder identification, method and frequency of communication, scope, and prioritization. Identifies project issues and risks and creates a risk mitigation plan for small- to medium-sized projects. Manages project performance (e.g., on time, on budget, within scope, and with quality) for projects of small to medium size or complexity. Promotes project vision and objectives within project team and ensures project objectives are met. Supports the compliance of project plans by following best practices and procedures. Promotes collaboration with diverse project stakeholders. Level of Responsibility Taking responsibility for own work and making decisions with limited impact; impact of decisions is readily apparent Solid understanding of how people go through a change and the change process with knowledge of change management principles, methodologies and tools. Using verbal and written communication skills to convey basic, routine information about day-to-day activities to others who are fully knowledgeable in the subject area. Completing tasks that require multiple steps that must be performed in a specific order, using directions or manuals that accurately document the steps necessary to perform the tasks. Using deductive problem solving is required to solve moderately complex problems; most problems have defined processes of diagnosis/detection; some data analysis may be required. Exercising some creativity may be required to troubleshoot technical problems or deal with novel circumstances. Minimum Qualifications: Bachelor's degree. 4+ years of Finance, Accounting, or related work experience. *Completed advanced degrees in a relevant field may be substituted for up to two years (Masters = one year, Doctorate = two years) of work experience. Experience Level- 5+ Years, Project/Change certified + successfully delivered Shift timing- EMEA shift (3 pm IST to 12 am IST), but should be flexible based on business needs Applicants Qualcomm is an equal opportunity employer. If you are an individual with a disability and need an accommodation during the application/hiring process, rest assured that Qualcomm is committed to providing an accessible process. You may e-mail disability-accomodations@qualcomm.com or call Qualcomm's toll-free number found here. Upon request, Qualcomm will provide reasonable accommodations to support individuals with disabilities to be able participate in the hiring process. Qualcomm is also committed to making our workplace accessible for individuals with disabilities. (Keep in mind that this email address is used to provide reasonable accommodations for individuals with disabilities. We will not respond here to requests for updates on applications or resume inquiries). Qualcomm expects its employees to abide by all applicable policies and procedures, including but not limited to security and other requirements regarding protection of Company confidential information and other confidential and/or proprietary information, to the extent those requirements are permissible under applicable law. To all Staffing and Recruiting Agencies Please do not forward resumes to our jobs alias, Qualcomm employees or any other company location. Qualcomm is not responsible for any fees related to unsolicited resumes/applications. If you would like more information about this role, please contact Qualcomm Careers.
Posted 2 months ago
2.0 - 6.0 years
4 - 8 Lacs
Ahmedabad
Work from Office
About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Sr Executive LLM (NPD) Job Requisitions No : 9102 Job Description Purpose of Job Skill Required Roles and Responsibilites Qualification Required Competencies Intas Action Oriented Intas Customer Focus Intas Dealing with Ambiguity Intas Problem Solving Intas Time Management Relevant Skills / Industry Experience Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: Ahmedabad, GJ, IN, 380054 Travel: 0% 25% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 11 Apr 2025
Posted 2 months ago
3.0 - 7.0 years
5 - 9 Lacs
Daskroi
Work from Office
About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Senior Executive Regulatory Affaris Job Requisitions No : 13246 Job Description Purpose of Job The purpose of the job is to take the responsibility of Dossier requests received from internal business partners, Skill Required Experience of handling registrations of biosimilars in regulated and semi regulated markets, Experience of drafting dossier sections Experience of drafting query responses Experience of interactions and co-ordination with CFTs Strong communication skills Experience of handling RA tools Roles and Responsibilites Summary Of Job Functions Responsible for preparation of regulatory submissions (regulated and semi regulated markets) Key Responsibilities Responsible for authoring IMPD and MAA by collating all the documents for registration of biosimilar products in regulated market EU/US/ROW regions Preparation of scientific advice and briefing book documents for biosimilars Preparation of responses to queries received from various regulatory agencies To work within regulatory teams for effective preparation of CMC documents for regulated and semi regulated markets, Updating and maintaining the regulatory trackers with the required details Provide necessary regulatory assessment for change controls Qualification Required Pharm/B Biological experience is added advantage/preferable Competencies Intas Action Oriented Intas Customer Focus Intas Dealing with Ambiguity Intas Problem Solving Intas Time Management Relevant Skills / Industry Experience Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: Ahmedabad, GJ, IN, 382213 Travel: 0% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 11 Apr 2025
Posted 2 months ago
1 - 5 years
8 - 13 Lacs
Mumbai
Work from Office
About The Role : Job titleBond Analytics Analyst Location:Mumbai, India Corporate title Associate Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS) With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team at Deutsche Bank has long been recognized as a leader in the provision of administrative and fiduciary services to the global debt and equities markets. It supports structures from the simplest to the most complex, covering Asset Backed Securities, CLOs and Managed accounts, Corporate Debt, Escrows, Project Finance, Loan Agency, and Depositary Receipts. OverviewTeam TAS Analytics group within Corporate Trust business of Deutsche Bank is supporting the Structured Finance products like ABS/MBS/CDOs and other Debt products like Syndicated Loan transactions where DB acts as Trustee and/or Agent. As Trustee and/or Agent, DB is responsible for performing various calculations including but not limited to Bond Payments and Tax Calculations for new and existing bond issuances. Group has exposure to Corporate Trusts business in understanding the Structured Finance and other Debt products and its Analytics requirements along with supporting the CSG activities. The successful candidate will be required to cover European working hours supporting the EMEA/Americas business. Corporate title will depend on the relative experience of candidate. What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Flexible working arrangements Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Read and interpret governing legal and issuer documents namely Prospectuses/Offering Circulars, Bond Indentures and Pooling and Servicing Agreements, Hedging Agreements, etc. Process and review Bond Payments for MBS, ABS, CDO and similar kinds of structured product deals in an In-House platform (iMAKE) based on the Offering Circulars/Indenture/Pooling & Servicing Agreement and using the best practices followed in the Group. Offer the highest level of customer service by understanding overall deal structure and bond payments to provide internal and external clients with explanations to support cash flow model output. Establish the guidelines for receipt and appropriate format of underlying asset-level collateral that supports bond payments, as well as research and resolve any data accuracy issues. Involvement in ad hoc/special projects which support process improvement and the implementation of technology initiatives. Understand and analyze issues and offer practical solutions. Working independently with a minimal degree of supervision is required to exercise independent judgment. Your skills and experience Bachelor of Science/Engineering or qualified CA/CFA with a high GPA and a minimum of 2 years of professional experience. Previous experience in developing cash flow models, and exposure to securities industry. Must have proven skills in MS Excel and/or MS Access with good scripting skills in VBA. Experience in using SQL Demonstrated ability to handle multiple and often competing projects under tight deadlines and pressure. Must project a Customer/Client service focus. Responsible for supporting efforts to mitigate and control operational risk. Must be organized, focused, and possess strong communication and analytical skills. Demonstrated ability to work and think independently, while supporting team goals/objectives. How we'll support you Training and development to help you excel in your career Flexible working to assist you balance your personal priorities Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.
Posted 2 months ago
4 - 9 years
30 - 32 Lacs
Bengaluru
Work from Office
About The Role : Job titleBond Analytics Analyst Corporate titleAVP LocationBangalore, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team at Deutsche Bank has long been recognized as a leader in the provision of administrative and fiduciary services to the global debt and equities markets. It supports structures from the simplest to the most complex, covering Asset Backed Securities, CLOs and Managed accounts, Corporate Debt, Escrows, Project Finance, Loan Agency, and Depositary Receipts. OverviewTeam: TAS Analytics group within Corporate Trust business of Deutsche Bank is supporting the Structured Finance products like ABS/MBS/CDOs and other Debt products like Syndicated Loan transactions where DB acts as Trustee and/or Agent. As Trustee and/or Agent, DB is responsible for performing various calculations including but not limited to Bond Payments and Tax Calculations for new and existing bond issuances. Group has exposure to Corporate Trusts business in understanding the Structured Finance and other Debt products and its Analytics requirements along with supporting the CSG activities. The successful candidate will be required to cover European working hours supporting the EMEA/Americas business. Corporate title will depend on the relative experience of candidate. What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Flexible working arrangements Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Read and interpret governing legal and issuer documents namely Prospectuses/Offering Circulars, Bond Indentures and Pooling and Servicing Agreements, Hedging Agreements, etc. Process and review Bond Payments for MBS, ABS, CDO and similar kinds of structured product deals in an In-House platform (iMAKE) based on the Offering Circulars/Indenture/Pooling & Servicing Agreement and using the best practices followed in the Group. Offer the highest level of customer service by understanding overall deal structure and bond payments to provide internal and external clients with explanations to support cash flow model output. Establish the guidelines for receipt and appropriate format of underlying asset-level collateral that supports bond payments, as well as research and resolve any data accuracy issues. Involvement in ad hoc/special projects which support process improvement and the implementation of technology initiatives. Understand and analyze issues and offer practical solutions. Working independently with a minimal degree of supervision is required to exercise independent judgment. Your skills and experience Bachelor of Science/Engineering or qualified CA/CFA with a high GPA and a minimum of 2 years of professional experience. Previous experience in developing cash flow models, and exposure to securities industry. Must have proven skills in MS Excel and/or MS Access with good scripting skills in VBA. Experience in using SQL Demonstrated ability to handle multiple and often competing projects under tight deadlines and pressure. Must project a Customer/Client service focus. Responsible for supporting efforts to mitigate and control operational risk. Must be organized, focused, and possess strong communication and analytical skills. Demonstrated ability to work and think independently, while supporting team goals/objectives. How we'll support you Training and development to help you excel in your career Flexible working to assist you balance your personal priorities Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.
Posted 2 months ago
2 - 7 years
3 - 8 Lacs
Ahmedabad
Work from Office
Walk-in at Matoda We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Role & responsibilities QUALITY ASSURANCE IPQA (Injectable), IPQA (OSD) & QMS / Documentation / Validation and Qualification (Officer / Senior Officer / Executive/Senior Executive) Experience - 02 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / M.Sc. Injectable Manufacturing Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI OSD Manufacturing / Dispensing / QMS (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification B Sc / M Sc / B. Pharmacy/ M Pharmacy / Diploma Time and Venue : 17th May 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. Preferred candidate profile *Having relevant qualification as mentioned above can attend the scheduled walk-in.
Posted 2 months ago
10 - 15 years
14 - 15 Lacs
Dadra & Nagar Haveli
Work from Office
Maintain the microbiology laboratory as per regulatory requirements. Planning and coordination with cross functional team for timely release of the RM,FP, Stability samples. Handling of microbiology related OOS/OOT, Deviation, Lab event. Prepare the response and closure of audit observations. Change control management for revision of SOP s, Validation protocol. Ensure the availability of resources of microbiology laboratory. Ensure the microbiologist certification program of all microbiologist. Implementation of new projects for cost saving, compliance enhancement , work simplification. Having technical knowledge of following major test MLT of OSD products and MLT validation. Disinfectant efficacy test ( Disinfectant Validation) Maintenance of microbial cultures Maintenance of Microbiological media, Growth promotion test. Autoclave validation LAF, Biosafety cabinet, Incubators, pass box validation. Objectionability assessment of identified inhouse isolates. ALCOA++ Good knowledge of various guidelines like ISO14644, HTM 2010, EU Annex 1, 4, WHO, USP chapter 60, 61, 62, 1115, 1116, 1072, 21 CFR regulations Part 210, 211 Environment monitoring program design, risk evaluation, Location selection, Alert and action limit establishment. Purified water system validation. Chemical and microbial analysis of water. 10. Audit experience for FDA, MHRA. ANVISA, TGA etc. 11. Handling of software following but not limited: SLIMS, Lonza Moda, Equisoft, Vitek 2 compact software, High air flow, ICDAS, Trackwise, EDAMS, LMS, e residue , Lab X software, TOC software 12. Hands on experience of major instruments like: Vitek 2 system, TOC analyser, Autoclave, Conductivity meter, Air sampler, Digital Microscope, LAF, Biosafety cabinet.
Posted 2 months ago
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