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1.0 - 3.0 years
0 - 3 Lacs
noida
Work from Office
1. Drug Regulatory Affairs - Job description Prepare CTD, ACTD Dossiers and file regulatory submissions Perform assessments of new or revised products Manage complaint documentation (including investigation and closure) Respond to inquiries from regulatory bodies Should be technically well versed with requirements for Medicines with fare knowledge about Food supplement, medicines To Coordinate with relevant department for arranging documents To prepare / compile dossier for allocated products / countries To coordinate with account department for handling Local FDA fees / transfer of amount for legalization etc To coordinate with courier agency for dispatches of dossier /samples To make timely entries of submissions / dispatches Qualifications :- A bachelors degree in B. Pharma Experienced with 1 year Should apply. Excellent communication skills Should be aware about Microsoft office [word / Excel/ PPT] - Good inData management Contact No- 8810226562
Posted 4 days ago
3.0 - 5.0 years
3 - 4 Lacs
navi mumbai
Work from Office
Role & responsibilities Exploration of updated guidelines needed for dossier compilation for ROW market/ Regulated Market. Preparation, compilation, review, and submission of Pharmaceutical Dossiers to emerging market as per International Conference on Harmonization (ICH) and country specific guidelines in Common Technical Document (CTD), Asian Common Technical Document (ACTD) and regional format. Internal communication & follow-ups with various departments for various documents. To arrange and send samples for registration purpose to various countries. Review at all quality data received from various departments before using in dossiers and technical packages. Preparation and submission of Query response raised by the Health Authority. To undertake any other assignment given by superior of the department / management from time to time. To support in documentation in national and international tenders. Management of Product Database. Archival of dossier. For COPP Application- Support with documents. Preferred candidate profile Must be from Formulation background interested applicant can send CV on shital@mjbiopharm.com , janhavi.shedekar@mjbiopharm.com or contact on 9867700982. Perks and benefits
Posted 5 days ago
1.0 - 5.0 years
0 Lacs
vadodara, gujarat
On-site
As a Jr. Officer to Sr. Officer at our company, you will be responsible for the following: - Preparation of dossiers and documents in compliance with CTD, ACTD, and country-specific guidelines. - Reviewing dossiers, DMF, and technical documents. - Addressing queries raised by regulatory authorities. Qualification Required: - Must have an M.Pharm degree. The work location for this position is in Jarod, Vadodara, Gujarat. Additionally, we offer benefits such as health insurance, leave encashment, life insurance, paid sick time, and provident fund. Please note that this position requires a long-term association agreement with an incentive scheme for 2-3 years.,
Posted 5 days ago
2.0 - 7.0 years
8 - 12 Lacs
gurugram
Work from Office
Location: Gurgaon Regulatory and Safety Affairs is a critical function within R&D: a key partner in developing the right portfolio strategy for brilliant innovation, activation in our markets and secure the products during all product life cycle. We actively engage externally with stakeholders and regulators to anticipate and credibly influence changes to the regulatory environment, and we bring that regulatory intelligence back to Reckitt to drive better informed business decisions. We lead the thinking internally about what is possible and put forward ideas that become reality, acting as stewards of our brands and our company to deliver compliant and competitively positioned products to the people we serve. Data, and data accuracy Is a foundational element of regulatory processes and directly influences the effectiveness of the organisation and its ability to deliver compliant and competitively positioned products. As Regulatory Operations Specialist Publishing you will be responsible for the compilation and publishing of all regulatory data packages required across the product lifecycle stages, initially focused on the global medicinal portfolio and will reach further into other classifications once established. In your role you will be responsible for the quality, accuracy, and timely population of data within the key business systems which support publishing activities. You will become a subject matter expert in the use of these systems and the business processes which support them. You will partner with the wider Operations Regulatory team to understand and meet its publishing needs. You will lead reviews with the wider Operations Regulatory team to feed back on publishing activities ensuring we deliver to key stakeholders in areas such as accuracy, timeliness etc. Where required, and in conjunction with the wider Operations Regulatory teams, you will use continuous improvement methodology to improve internal business processes and systems which support Publishing activities. You are proficient in the field of publishing, and you will use your experience to execute your role effectively and to a high level of compliance with the applicable standards and external industry expectations. You will play an important role because. We’re proud of our organisation and continually strive to be the best that we can be. The Regulatory Operations - Publishing plays an essential role in leading a team that deliver critical services to the broader Regulatory Operations function. You will succeed because ... You bring prior experience in the field of regulatory publishing, with a strong track record of successful delivery. You are skilled in the identification of key stakeholders and have a strong capability for building mutually beneficial partnerships based on openness and transparency. Have good communication skills and capability to keep key stakeholders consistently informed and updated across a broad range of subjects and processes in real time. You have broad knowledge of regulatory processes, with particular emphasis on medicines, but experience in other classifications is considered beneficial. You have knowledge of the medicinal dossier structure and regulations / guidance for global markets, medicinal publishing requirements, document repositories, common validation publishing challenges, and management of sequences and submission tracking throughout the product lifecycle. You will have knowledge of the worldwide publishing standards including, Nees, ACTD, eCTD, US, Swiss and South Africa Have knowledge or experience in the use of publishing tools / solutions such as Lorenz Documbridge etc. Ability to consistently deliver to time, cost and quality standards in a high-pressure environment. Demonstrates courage and empathy and work collaborative cross-functional, through change by adopting a growth and compliance mindset and inclusive/expansive leadership. Key Responsibilities of the Role will include Responsible for delivering all publishing activities on time and to a high-quality standard. All publishing activities includes: collating all required documents, compilation, validation of all modules and publishing of the dossier/ensuring the submission package is ready for publishing. Fostering productive relationships with those stakeholders critical to your role and maintaining high level of communication to ensure buy in and engagement. You will apply the principles of continuous improvement to consistently and critically review internal processes to identify and deliver increased efficiency, compliance or other business benefit. Training your publishing team to a high level of knowledge and competency in publishing processes. Deliver regular updates on work deliveries, transparency in the execution plans and dates, project management alongside reg ops teams.
Posted 1 week ago
5.0 - 10.0 years
3 - 8 Lacs
ahmedabad
Work from Office
Key Responsibilities Prepare, review, and submit CTD/ACTD/eCTD dossiers for international markets Develop and execute regulatory strategies for ROW, LATAM, SEA, Africa, and Pacific regions Manage product registration, renewals, variations, and post-approval compliance Ensure compliance with WHO-GMP, ICH, and country-specific regulatory guidelines Coordinate bioequivalence studies and relevant documentation Review technical files and maintain up-to-date regulatory documentation Liaise with regulatory authorities, internal departments, and external partners Mentor junior RA team members and drive process improvements Requirements B.Pharm / M.Pharm / Life Sciences background Minimum 6 years experience in Regulatory Affairs within the pharmaceutical industry Proficient in CTD/ACTD/eCTD dossier compilation Experience with parenteral dossiers (preferred) Exposure to global regulatory submissions and product lifecycle management Proficient in MS Office, with strong communication and leadership skills
Posted 1 week ago
4.0 - 9.0 years
5 - 9 Lacs
thane
Work from Office
Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands company€™s customer base and ensure it€™ s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status
Posted 1 week ago
3.0 - 8.0 years
10 - 14 Lacs
hubli
Work from Office
To drive sales and ensure business targets are achieved o Aggressively drive the sales numbers and achieve the business targets for Retail loan products and through cross selling while continuing to enhance and upgrade the client relationships.o Retain and expand the company's base of customers for retail loan product so as to ensure repeat business or referralso Maximize sales through a network and relationships to ensure strong businesso Develop and maintain strong liaisons with the clients for repeat business or referrals.o Ensure the files are processed from login stage to disbursement and liaise with internal departments (Operations and Credit) for completion.o Optimize team productivity by effectively managing the team of relationship managers so as to assure achievement of team results and thereby meet the business targets and profitability of the areao Align with the team on ground lead generation activities for Sales.o Lead and supervise the team for the implementation of the growth agenda through appropriate training, motivation and deployment strategieso Constantly keep abreast on market trends and competitor intelligence so as to build and develop effective sales and marketing strategieso Use understanding of the markets / competition / process and products available in the markets to provide positive feedback to the central product and policy team to stay ahead in the market.o Ensure compliance to all Audit / RBI regulations as well as processes, policies and reports as per company designed systems. Post Graduate/ Graduate in any discipline
Posted 2 weeks ago
1.0 - 7.0 years
25 - 30 Lacs
kolkata, new delhi
Work from Office
Perpetuity Capital is looking for AREA SALES MANAGER to join our dynamic team and embark on a rewarding career journey Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status
Posted 2 weeks ago
11.0 - 18.0 years
11 - 17 Lacs
ahmedabad
Work from Office
Role & responsibilities 1.Prepare monthly regulatory MIS reports and present status updates, key metrics, and strategic insights to senior management. 2. Manage relationships with external regulatory consultants, in-country partners, submission vendors, and the external regulatory team to ensure timely regulatory filings and ongoing compliance. 3. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. 4. Liaise with regulatory authorities including (EU, CIS, LATAM, ROW, Asia) and others. 5.Develop and implement regulatory strategies across international markets (EU, CIS, LATAM, ROW, Asia, Middle East, and Georgia) to ensure timely submissions and approvals for product registrations and lifecycle maintenance. 6. Lead the preparation, review, and submission of CTD/eCTD/ACTD dossiers for multiple dosage forms including solid orals, injectables, topicals, and liquids for pharmaceutical and nutraceutical products, as per country-specific guidelines. 7.Manage lifecycle regulatory activities such as renewals, variations, line extensions, and prompt responses to health authority queries across global jurisdictions. 8.Maintain up-to-date knowledge of global regulatory and provide strategic recommendations based on updated guidelines and country-specific requirements. 9.Ensure regulatory compliance for labeling, artworks, inserts, and packaging as per regional regulations and internal quality standards. 10 .Support and participate in regulatory audits and inspections by ensuring the availability of complete and updated documentation and responses. 11.Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives.
Posted 2 weeks ago
3.0 - 5.0 years
2 - 6 Lacs
bengaluru
Work from Office
About The Role Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Regulatory, helping the world s leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory affairs LCM tasks of building dossiers and Coordination for LCM activities accordance with ICH and Global Requirements and guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.Collect, collate and evaluate the scientific data gathered as part of R & D. Advise on scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example Build regulatory submission strategy, author regulatory documents, and health authority packages etc. What are we looking for? Life Sciences Regulatory ServicesAbility to manage multiple stakeholdersAbility to meet deadlinesAbility to perform under pressureAbility to work well in a teamAgility for quick learningVeeva Vault and Regulatory Life Sciences Requirements Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Master of Pharmacy
Posted 2 weeks ago
5.0 - 7.0 years
5 - 8 Lacs
ahmedabad
Work from Office
Role & responsibilities To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all LATAM, MENA, CIS and ROW Countries and other country as per company requirements. Responsible for final review of dossier before submission. To coordinate with technical team for documents required for dossier. Responsible to gather data related for dossier through online sources, laboratories, manufactures, etc. Reviewing artwork for products as per relevant regulatory authority requirements. To verify the text matter, including text for product information leaflets and labels for medicines in accordance with the regulatory and code of conduct requirements; Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives. Preferred candidate profile Qualification: B. Pharm and M. Pharm Experience: Minimum 5 years in ROW market for Formulation Dossier preparation and submission Perks and benefits Salary: 40,000 to 70,000 per month Mediclaim Bonus
Posted 3 weeks ago
3.0 - 8.0 years
2 - 4 Lacs
vadodara
Work from Office
Responsibilities As a regulatory affairs officer: ensure that a company's products comply with the regulations of the regions where they want to distribute them keep up to date with national and international legislation, guidelines and customer practices respond to queries from medical bodies like the Medicines and Pertaining to that Guidelines. collect, collate and evaluate scientific data from a range of sources develop and write clear arguments and explanations for new product licences and licence renewals prepare submissions of licence variations and renewals to strict deadlines monitor and set timelines for licence variations and renewal approvals work with specialist computer software and resources write clear, accessible product labels and patient information leaflets plan and develop product trials and interpret trial data advise scientists and manufacturers on regulatory requirements provide strategic advice to senior management throughout the development of a new product project manage teams of colleagues involved with the development of new products oversee product trials and interpret trail data undertake and manage regulatory inspections review company practices and provide advice on changes to systems liaise with, and make presentations to, regulatory authorities negotiate with regulatory authorities for marketing authorisation take part in the development of marketing concepts and approve packaging and advertising before a product's release. Role & responsibilities Preferred candidate profile
Posted 3 weeks ago
0.0 - 1.0 years
3 - 6 Lacs
coimbatore
Work from Office
Role / Nature of Job : Assembly / Machine Operator Follow and support Safety and Environmental practices on the shop floor, including hazard identification and safe working methods, in line with ISO45001 & ISO14001 standards. Operate machines and follow established processes after required training, ensuring adherence to ISO9001:2015 standards. Support shift production targets by executing assigned operations and coordinating with relevant support teams. Maintain discipline in resource usage to support cell-level productivity and cost control (Volume-adjusted VOH). Carry out production activities as per the shift plan to meet internal customer requirements. Build skills through On-the-Job Training (OJT) and take responsibility for multiple tasks as part of multi-skilling efforts. Assist in tracking and reporting key manufacturing performance indicators (KPIs). Apply Lean principles in daily work and actively contribute improvement ideas to relevant stakeholders. Work on machines such as CNC Horizontal Turning Centers, OD Grinding, HMC, and CNC Gear Grinding as assigned / Assembly line to meet the necessary target. Safely handle heavy components using overhead cranes and follow proper placement procedures. Read and understand engineering drawings and apply them in part machining and inspection. Follow 5S, FIFO, Kanban, CIS, and Kaizen practices in day-to-day operations. Your Profile : Diploma / BE.,(from Tier 3 or 4 college) in Mechanical / Automobile/ Manufacturing/ Production/ Metallurgy / Agriculture 0 - 1 Years experience in Production / Assembly as Operator Be part of our ZF team as Assembly / Machine Operator and apply now!
Posted 3 weeks ago
6.0 - 9.0 years
6 - 8 Lacs
navi mumbai
Work from Office
Role & responsibilities Dossier Preparation and Submission: Compile and review regulatory submissions in ACTD, CTD and formats. Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements. Review of Plant and R&D Data: Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies. Regulatory Compliance and Updates: Stay informed of changes in Asian or Regulated market regulations, ensuring timely implementation of updates to maintain compliance. Provide regulatory insights to internal teams on best practices for data management and documentation. Documentation and Record Keeping: Maintain well-organized records of submissions, communications, and approvals. Use regulatory software and systems for document tracking, version control, and report generation. Markets - Regulated (EU/UK/Aus) or ROW (Asia & Africa) Desirable Skills & Competencies: Attention to Detail: Ability to review and analyze technical documentation with precision. Collaboration: Effective communication skills for working with R&D, manufacturing, and quality assurance teams. Problem Solving: Proactive in identifying compliance issues and developing solutions to address regulatory challenges. Proficient in MS Office and regulatory documentation software. Interested candidates can apply or mail your resume on vaibhavi.b@titanpharma.com or -contact 022 - 6785 7000 (Ext 725). If you have good references you can share on above details. Thanks & Regards, Vaibhavi Behere HR Department Titan Laboratories Pvt Ltd
Posted 3 weeks ago
1.0 - 3.0 years
3 - 5 Lacs
bengaluru, whitefield
Work from Office
We are seeking a Regulatory Affairs Executive with 1 to 3 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Responsibilities include preparing, compiling, and maintaining regulatory documentation in accordance with regional requirements, coordinating with cross-functional teams to gather necessary data, and ensuring timely submission of dossiers. The candidate should be well-versed with regulatory guidelines, and capable of handling multiple projects simultaneously.
Posted 3 weeks ago
4.0 - 8.0 years
6 - 6 Lacs
ahmedabad
Work from Office
We are hiring a highly experienced Senior Regulatory Affairs Executive for our pharma company in Ahmedabad. The role involves dossier preparation & submission (CTD/ACTD/eCTD), product registration, regulatory strategy, compliance with WHO-GMP/ICH/global guidelines, and handling ROW, LATAM, SEA, Africa, Pacific market approvals. The candidate will also coordinate BE studies, manage lifecycle activities, review technical files, liaise with authorities, maintain regulatory records, and mentor junior team members.
Posted 3 weeks ago
3.0 - 5.0 years
3 - 6 Lacs
chennai
Work from Office
Job Description: Regulatory Affairs Executive (ROW Markets) Industry: Pharmaceuticals Experience: 3-5 Years Loaction: Chennai Key Responsibilities: Dossier Submissions: Compile & submit ACTD, CTD, and country-specific dossiers for ROW markets. Regulatory Queries: Prepare and respond to health authority queries on submitted dossiers. Document Review: Review BMR, specifications, COA, MOA, and technical documents for compliance. Artwork Coordination: Ensure accuracy in labeling & packaging artwork with regulatory standards. FDA Compliance: Maintain records for FDA licenses (Product Permission, CoPP, FSC) . Legal Documentation: Track notarized & legalized documents for international submissions. Eligibility & Requirements: Education: B.Pharm / M.Pharm (Pharmacy graduates preferred). Experience: 3-5 years in regulatory affairs, dossier submissions, or pharma compliance . Skills: Strong knowledge of ACTD/CTD dossier formats . Familiarity with FDA, EMA, and ROW market regulations . Attention to detail in documentation & compliance checks . Proficient in regulatory tracking systems & MS Office .
Posted 3 weeks ago
4.0 - 6.0 years
8 - 10 Lacs
bengaluru
Hybrid
• Develop and review content for various regulatory documents; ensure quality as per setegulatory standards and compliance requirement. • Good understanding of global regulatory dossier formats and ACTD/CTD/NeeS/paper dossier format. • Candidate will need to author and/or review clinical and non-clinical documents under Module 2, 4 and 5 of eCTD, and Part III and Part IV of ACTD for submission to the Health Authorities in EU and APAC markets, respectively. Key requirement: • Good medical/pharma/scientific knowledge that can be applied in developing content for regulatory documents • Experienced in the development and review of clinical and non-clinical documents under Module 2, 4 and 5 of eCTD, and Part III and Part IV of ACTD, for submission to the regulatory authority in EU and APAC regions, respectively • Good understanding of clinical trial and product life cycle EDUCATION: MBBS/PhD/MDS/BDS/MPharm/PharmD/BPharm/MSc EXPERIENCE: 4 to 6 years of Regulatory Writing/Reviewing experience LOCATION: Bangalore (Office-based/Hybrid) SKILLS: • Good communication skills (Written and Oral) • MS Office (Excel and Power point) PRINCIPAL RESPONSIBILITIES & ACCOUNTABILITIES: • Broad Area-1: Develop Content to Meet High CSAT Independently (Simple and Complex Projects) o Responsible for developing new drafts/updating existing content/review with quality, accuracy, timelines, and efforts, independently (Protocol, Informed Consent Form [ICF], Investigators Brochure [IB], clinical and non-clinical documents under Modules 2, 4 and 5 of eCTD and, Part III and IV of ACTD) o Responsible to run and review literature searches in various databases and screening articles to obtain required information for content development o Good knowledge of various regulatory guidelines and regulatory dossiers related to regulatory content development o Conduct quality checks to ensure the accuracy and consistency of data included in documents o Build expertise in extracting information from textbooks, authentic websites and articles for different deliverables and therapeutic areas o Demonstrate good technical competence on how to search the internet and books for referencing, copyrights, and plagiarism o Follow the best practices while executing projects in the team with regard to processes, communication (internal and external), documentation and technical requirements like language, grammar, style, content search, summarizing, data conflicts and referencing o Analyze challenges/limitations in content development and provide logical, unbiased, and rational recommendations for modifying quality standards or introducing newer ones o Work with internal stakeholders for project execution and actively participate in team meetings and client meetings from a content perspective • Broad Area-2: Review Content of Team Members o Review the content prepared by junior team members. Validate the authenticity of the content by performing data fact check o Guide team members on content client requirements and quality aspects of content development for different deliverables development (including but not limited to Protocols, IBs, ICF, clinical and non-clinical documents under Modules 2, 4 and 5 of eCTD and, Part III and IV of ACTD), o Guide team members to develop content outlines for different target groups that are accurate, clinically relevant, reflecting the most recent medical advances and in accordance with established content development practices, in collaboration with clients and team leads • Broad area-3: Process Adherence and Compliance o Be aware of all organizational, divisional, and client-related policies and procedures related to quality, information security and data privacy o Responsible to strictly adhere to quality standards for various deliverables as decided by the business unit or client o Responsible to maintain confidentiality and copyright rules for various deliverables/clients and company norms o Follow all the security rules with regard to various standards like ISMS, ISO, CMMI and client guidelines • Broad Area-4: Self-Development o Support in developing technical training programs for other team members relevant to the job o Responsible to complete client-specific training, if applicable o Responsible to build expertise in assigned deliverables through self-learning and formal trainings and stay abreast with current trends in the respective areas o Learn the basic skills to manage teams o Participate in and contribute to various continuous improvement initiatives or company driven initiatives Interested Candidate Please Apply - India.hr@infinitysts.com
Posted 3 weeks ago
5.0 - 10.0 years
4 - 8 Lacs
ahmedabad
Work from Office
Role & responsibilities Preparation of DMF / ASMF / CEP dossiers as per the ICH M4 CTD/eCTD guidelines. Response preparation as per the query Preparation of renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authorities requirements Coordination with various departments to collect the necessary information required for preparation of the CTD / ACTD / Country specific dossier. Assist in preparation of dossier as per country specific requirement. Any other job assigned by immediate supervisor/HOD Preferred candidate profile Hiring for API & Formulation background candidates for Regulatory Affairs Team Good Communication Skill in English
Posted 3 weeks ago
5.0 - 6.0 years
3 - 6 Lacs
ahmedabad
Work from Office
Job Responsibilities: Dossier preparation/review as per country specific guideline/CTD guideline Timely query response submission to Distributor/ MOH Review of documents for its correctness and compliance with respective regulatory guidelines (as per country requirement) Preparation, review & release of artworks & sales order as per country approval Variation documents preparation and filing as per country requirements Timely dispatch of tender documents to country/parties as per deadline Candidate profile Should be able to review & interpret the requirement as per country specific/ tender guideline/Query received from MOH Should be able to review various plant documents for dossier preparation like Process validation, Stability study, PDR, Method validation, SOP, Drug Master File, BMR, APR etc. Should be able to communicate with relevant functions for procurement of required regulatory documents Should be able to communicate with relevant business partner at country
Posted 3 weeks ago
3.0 - 7.0 years
8 - 13 Lacs
mumbai, new delhi, pune
Work from Office
To drive sales and ensure business targets are achieved o Aggressively drive the sales numbers and achieve the business targets for Retail loan products and through cross selling while continuing to enhance and upgrade the client relationships.o Retain and expand the company's base of customers for retail loan product so as to ensure repeat business or referralso Maximize sales through a network and relationships to ensure strong businesso Develop and maintain strong liaisons with the clients for repeat business or referrals.o Ensure the files are processed from login stage to disbursement and liaise with internal departments (Operations and Credit) for completion.o Optimize team productivity by effectively managing the team of relationship managers so as to assure achievement of team results and thereby meet the business targets and profitability of the areao Align with the team on ground lead generation activities for Sales.o Lead and supervise the team for the implementation of the growth agenda through appropriate training, motivation and deployment strategieso Constantly keep abreast on market trends and competitor intelligence so as to build and develop effective sales and marketing strategieso Use understanding of the markets / competition / process and products available in the markets to provide positive feedback to the central product and policy team to stay ahead in the market.o Ensure compliance to all Audit / RBI regulations as well as processes, policies and reports as per company designed systems. Post Graduate/ Graduate in any discipline Location - Mumbai,New Delhi,Pune,Bangalore,Hyderabad,Chennai
Posted 4 weeks ago
3.0 - 8.0 years
0 - 1 Lacs
Bengaluru
Work from Office
Lead Analyst- Emerging Markets Strategy: Elevate Your Impact Through Innovation and Learning Evalueserve is a global leader in delivering innovative and sustainable solutions to a diverse range of clients, including over 30% of Fortune 500 companies. With a presence in more than 45 countries across five continents, we excel in leveraging state-of-the-art technology, artificial intelligence, and unparalleled subject matter expertise to elevate our clients' business impact and strategic decision-making. Our team of over 4, 500 talented professionals operates in countries such as India, China, Chile, Romania, the US, and Canada. Our global network also extends to emerging markets like Colombia, the Middle East, and the rest of Asia-Pacific. Recognized by Great Place to Work in India, Chile, Romania, the US, and the UK in 2022, we offer a dynamic, growth-oriented, and meritocracy-based culture that prioritizes continuous learning and skill development, work-life balance, and equal opportunity for all. Curious to know what its like to work at Evalueserve? Read on. About Investment Research (IR) As a global leader in knowledge processes, research, and analytics, youll be working with a team that specializes in global market research, working with the top-rated investment research organizations, bulge bracket investment banks, and leading asset managers. We cater to 8 of the top 10 global banks, working alongside their product and sector teams, supporting them on deal origination, execution, valuation, and transaction advisory-related projects. What you will be doing at Evalueserve Work directlywith the head of the team, who has been consistently ranked as the top analystin CEEMEA strategy by several top-tier investment banks. Handle research, strategy, and analytics for all EM fixed income-related products offered by theresearch platform of the banking client. Conduct macroeconomicand market research across emerging markets. Develop andmaintain financial models and analytical frameworks for EM fixed incomeproducts. Analyze largedatasets to identify market trends and investment opportunities. Support theteam in producing high-quality research reports and market commentary. Collaboratewith trading, sales, and risk teams to align strategy insights with businessneeds. Utilize toolssuch as Bloomberg, Macrobond, and Haver, and IMF databases for data extractionand analysis. What were looking for: Advanceddegree in economics /statistics /engineering with minimum relevant experienceof 3 years. Progress towards CFA / FRM is preferable. Priorexperience of macro research, financial modeling, structuring, trading, ormarket risk management Keen interestin global financial markets and knowledge of recent developments. Strongquantitative and mathematical skills with experience of working with largeamounts of data. AdvancedExcel, VBA analytical skills, and knowledge of basic econometrics is a must.Working knowledge of Python or R will be considered a plus. Excellentwritten and verbal communication skills ability to write research reports andcomment on market developments. Knowledge ofdatabase tools Bloomberg, Macrobond, Haver, World Bank, IMF, etc. Follow us on https://www.linkedin.com/compan y/evalueserve/ Click here to learn more about what our Leaders talking on achievements AI-powered supply chain optimization solution built on Google Cloud. How Evalueserve is now Leveraging NVIDIA NIM to enhance our AI and digital transformation solutions and to accelerate AI Capabilities . Know more about how Evalueserve has climbed 16 places on the 50 Best Firms for Data Scientists in 2024! Want to learn more about our culture and what its like to work with us? Write to us at: careers@evalueserve.com Disclaimer: The following job description serves as an informative reference for the tasks you may be required to perform. However, it does not constitute an integral component of your employment agreement and is subject to periodic modifications to align with evolving circumstances. Please Note: We appreciate the accuracy and authenticity of the information you provide, as it plays a key role in your candidacy. As part of the Background Verification Process, we verify your employment, education, and personal details. Please ensure all information is factual and submitted on time. For any assistance, your TA SPOC is available to support you.
Posted 1 month ago
5.0 - 8.0 years
12 - 17 Lacs
Thane, Navi Mumbai, Mumbai (All Areas)
Work from Office
We are looking for Regulatory Affairs - Executive / Sr. Executive handling Africa and Asia and will be based at Juinagar, Navi Mumbai. Minimum 5 Years in RA is must Roles & Responsibilities: 1. Dossier Preparation and Submission: Compile and review regulatory submissions in ACTD, CTD and formats. Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements. 2. Review of Plant and R&D Data: Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies. 3. Regulatory Compliance and Updates: Stay informed of changes in Asian and CIS market regulations, ensuring timely implementation of updates to maintain compliance. Provide regulatory insights to internal teams on best practices for data management and documentation. 4. Documentation and Record Keeping: Maintain well-organized records of submissions, communications, and approvals. Use regulatory software and systems for document tracking, version control, and report generation. Education: 5 - 8 years of experience in regulatory affairs, focusing on Asian markets. Desirable Skills & Competencies: Attention to Detail: Ability to review and analyze technical documentation with precision. Collaboration: Effective communication skills for working with R&D, manufacturing, and quality assurance teams. Problem Solving: Proactive in identifying compliance issues and developing solutions to address regulatory challenges. Proficient in MS Office and regulatory documentation software. Interested candidates can apply or mail your resume. If you have good references you can share - Thanks & Regards, Vaibhavi Behere HR Department Titan Laboratories Pvt Ltd vaibhavi.b@titanpharma.com
Posted 1 month ago
5.0 - 10.0 years
6 - 10 Lacs
Kolkata
Work from Office
Incoda Media is looking for Assistance Manager / Manager - Media Sales to join our dynamic team and embark on a rewarding career journey Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands company€™s customer base and ensure it€™ s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status
Posted 1 month ago
1.0 - 3.0 years
3 - 4 Lacs
Bengaluru
Work from Office
Role & responsibilities We are seeking a Regulatory Affairs Executive with 1 to 3 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Responsibilities include preparing, compiling, and maintaining regulatory documentation in accordance with regional requirements, coordinating with cross-functional teams to gather necessary data, and ensuring timely submission of dossiers. The candidate should be well-versed with regulatory guidelines, and capable of handling multiple projects simultaneously. Preferred candidate profile Regulatory Affairs, ACTD, CTD, Dossier Compilation, Pharma Regulatory, RA Executive
Posted 1 month ago
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