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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

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1.0 - 4.0 years

1 - 3 Lacs

noida

Work from Office

Urgent Hiring Overseas Job Counsellor Requirements: - Good Communication Skills - Knowledge of Computer & MS Excel - Email Handling - Sales & Convincing Skills - Target Oriented & Punctual

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17.0 - 27.0 years

20 - 30 Lacs

nagpur

Work from Office

Job Summary: We are looking for an experienced and strategic Regulatory Affairs leader to head our Regulatory function. The ideal candidate will oversee all regulatory submission activities, ensure timely approvals, maintain compliance with evolving global health authority requirements, and provide expert regulatory guidance for new and existing pharmaceutical products across ROW & regulated markets. Key Responsibilities Regulatory Strategy & Compliance: • Coordinate with agents, partners, and MOHs to define submission strategies. • Prepare internal strategy documents and lead regulatory discussions for new products. Dossier Management & Submissions: • Manage CTD/ACTD/eCTD submissions for new registrations, renewals, and variations. • Ensure dossiers and query responses are complete and compliant. • Coordinate with plants for registration samples and related documentation. Stakeholder Collaboration: • Work with internal teams and external partners to gather and finalize technical documents. Regulatory Operations Oversight: • Compile and submit responses to MOH/partner queries on time. • Track regulatory submissions as per calendar. • Oversee renewals of FDA licenses, WHO GMP, COPPs, etc. Training & Regulatory Intelligence: • Conduct training on updated guidelines. • Share critical regulatory updates with teams. Documentation & Reporting: • Review technical and administrative dossier sections. • Maintain monthly regulatory status reports. • Coordinate site registrations and pre-audit activities. Leadership & Team Development: • Guide the RA team for efficiency and compliance. • Promote process improvements and regulatory best practices. • Handle additional tasks under the RA function. neetij@selectsourceintl.com

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8.0 - 13.0 years

15 - 27 Lacs

pune

Remote

Job Title: Senior SAP ABAP Developer S/4HANA (LATAM Rollout Focus) About the Role: We are seeking a highly skilled Senior SAP ABAP Developer to support the expansion of our global S/4HANA 1909 template into the Latin America region. This role will play a key part in developing scalable, high-performance solutions tailored to the fintech industry, integrating localized requirements within a harmonized global framework. The ideal candidate will bring deep expertise in modern SAP development tools, including ABAP on HANA, CDS Views, OData, and SAP BTP. Key Responsibilities: • Design and build scalable, performance-optimized ABAP programs for S/4HANA, aligned with global template standards. • Develop and maintain CDS Views and OData services for SAP Fiori apps and external system integrations. • Integrate SAP S/4HANA with SAP BTP services and third-party systems to support end-to-end business processes. • Collaborate with functional consultants and regional teams to deliver localized enhancements for Brazil, Mexico, Colombia, and Panama. • Analyze and tune custom code performance in HANA-based environments. • Implement reusable components and enforce code quality, security, and maintainability standards. • Contribute to system upgrade and migration activities, ensuring development compatibility. • Prepare technical specifications and conduct peer reviews and knowledgesharing sessions. Required Qualifications & Skills: • 8+ years of hands-on SAP ABAP development experience, including ABAP on HANA (CDS, AMDP, performance optimization). • Strong experience with Object-Oriented ABAP and SAP enhancement techniques. • Deep knowledge of OData service development and consumption. • Experience with SAP Business Technology Platform (BTP), especially integration with S/4HANA. • Familiarity with SAP Fiori/UI5 development, extensions, and launchpad configuration. • Proven experience designing and maintaining SAP workflows (classic/BWF). • Participation in S/4HANA implementation or rollout projects (greenfield or brownfield). • Understanding of SAP Cloud Connector, authentication, and security models. • Strong analytical, debugging, and performance-tuning skills. • Ability to work independently in a fast-paced, multinational environment. Preferred Skills: • Exposure to SAP Integration Suite (API Management, Cloud Integration), BRF+, and SAP Analytics Cloud. • Understanding of DevOps concepts, CI/CD pipelines for SAP, and SAP Gitenabled Change and Transport System (gCTS). • Experience working within Agile/Scrum frameworks. • SAP Certification(s) in ABAP, S/4HANA Development, or BTP.

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2.0 - 7.0 years

5 - 9 Lacs

mumbai

Work from Office

WALK IN DRIVE R&D MUMBAI Interested candidates need to register through the QR code or link given below (works best on Google Chrome) https://macleods.in/HR/Ad.aspx?VAL=RjFndFFJSVZWY2lSQ2ZxQXBzdzczUT09 Department : Regulatory Affair Experience : 6 - 11 Years Designation : Sr. Executive/ Executive (US, Europe, South Africa, Africa, AU, NZ & Canada) Qualification : M.Pharma Location : Mumbai Job Descripition 6 -11 years of experience in pharmaceutical regulatory affairs, including leadership roles and expertise in global regulatory requirements and guidelines including FDA, EMA, and ICH regulations. Thanks & Regards HR Team

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4.0 - 8.0 years

8 - 18 Lacs

gurugram

Work from Office

Key Responsibilities: Market Expansion: Identify and evaluate new business opportunities in MEA, LATAM, and EU regions. Draft and execute GTM to key geographies Client Acquisition: Develop and execute strategies to acquire new distributor and partners in target markets. Alliance Management: Build and maintain strong relationships with key stakeholders, distributors, and partners. Market Intelligence: Conduct market research and competitor analysis to inform strategic decisions. Portfolio Management: Develop 5 year portfolio for Emerging markets Product Launches: Collaborate with internal teams to ensure on-time registrations and launches in territories Performance Tracking: Monitor KPIs and prepare regular reports on business development activities and outcomes. Travel: Willingness to travel internationally for client meetings, trade shows, and market visits.

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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

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2.0 - 3.0 years

24 - 36 Lacs

ahmedabad

Work from Office

Responsibilities: * Oversee regulatory affairs processes * Manage dossier submissions & preparations * Ensure compliance with the Latam market requirements * Lead row market strategies * Client query resolution. * Artwork review.

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7.0 - 11.0 years

8 - 12 Lacs

pune

Work from Office

Job Description Pharma Regulatory Affairs Manager Location: Pune, Maharashtra Department: Regulatory Affairs Reports To: Head – Regulatory Affairs / Senior Leadership Job Overview We are seeking a highly skilled and experienced Pharma Regulatory Affairs Manager to ensure compliance with global regulatory requirements and to support the successful development, approval, and commercialization of pharmaceutical products. The ideal candidate will bring deep expertise in regulatory affairs, strong leadership in navigating complex regulatory landscapes, and the ability to collaborate effectively with internal teams and regulatory authorities. Key Responsibilities Develop and implement regulatory strategies to ensure compliance with international and regional regulations . Prepare, review, and submit regulatory documents in line with global requirements (US, EU, and emerging markets). Liaise with regulatory authorities to address queries and obtain timely approvals. Monitor evolving regulatory guidelines and industry trends , assessing their impact on product development and commercialization. Partner with R&D, Quality, Clinical, and Legal teams to provide regulatory insights throughout the product lifecycle. Support documentation for clinical trials , including protocols, investigator brochures, and informed consent forms. Conduct risk assessments and provide recommendations for safety reporting and compliance obligations. Participate in audits and inspections , driving corrective and preventive actions as needed. Provide regulatory training and guidance to internal stakeholders to enhance compliance awareness. Qualifications & Requirements Education: Bachelor’s degree in Pharmacy or a related scientific field (Master’s preferred). Experience: 7 - 8 years in pharmaceutical regulatory affairs within a global organization. Strong knowledge of FDA regulations (21 CFR Part 11), ICH guidelines, EMA, and regional market requirements . Demonstrated success in regulatory submissions leading to product approvals. Proven project management skills , with the ability to manage multiple projects in a dynamic environment. Excellent written and verbal communication skills for engaging internal teams and external authorities. Strong analytical, problem-solving, and decision-making abilities. Proficiency in regulatory information management systems and related tools.

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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.

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9.0 - 14.0 years

18 - 25 Lacs

kolkata

Work from Office

Role & responsibilities Develop Sales Strategy for the Latin American markets Build and maintain relationships with clients and prospects Responsible for top line sales and increase of market share Develop the distribution network, identify buyers, negotiate and finalize business contracts Build and develop market intelligence for each country Developing long-term marketing plans and strategies to build the brand and create visibility in the market of the specified location. Responsible for end-to-end Sales and Export Operations Being aware of Exports related documentation and regulatory compliances Managing the team and overall budgets Attend all social, industry and business networking events in the region on behalf of the company Preferred candidate profile Should have experience in both sales and marketing. Team Handling experience (5-10 people) Travelling Experience is mandatory in the region Revenue handling experience of 7-8 Million USD per annum Well Versed in MS Office SAP Reporting Compatibility

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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

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3.0 - 8.0 years

7 - 12 Lacs

ahmedabad

Work from Office

We are Hiring ! Role: Territory Manager Location: Ahmedabad Role Objective:- To plan, acquire, execute and achieve goals in assigned business areas Receivables management Business Development Key Responsibilities: Overall responsibility of achieving the annual sales budget in Middle East. Sales forecasting and Budgeting Customer credit and receivables management Increase sales of DMF supported APIs Customer Relationship Management and Key account management New client identification and acquisition Product promotion by regular client visit and by participation in trade expositions Sales channel management New product identification and selection Train, mentor, groom and lead the team members Handle customer queries, complaints and resolve them effectively Provide competitive intelligence to the HOD and business head Any other actions and responsibilities as agreed with management

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6.0 - 10.0 years

6 - 7 Lacs

hyderabad

Work from Office

Role & responsibilities IT Recruitment for LATAM regions Preferred candidate profile More than five years in International IT recruitment with excellent communication skills in English and strong affinity with LATAM regions. Should have extensive experience in IT recruitment, technical recruitment for LATIN AMERICAN COUNTRIES & US IT recruitment is an added advantage. Should have the ability to screen the profiles negotiate the rate ( salary) , reviewing the documents, BGV. onboarding Etc. We are looking for immediate persons for this position to WFO. at Hitech - City, Hyderabad. People with own transport are preferred.

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2.0 - 5.0 years

5 - 14 Lacs

kochi, delhi / ncr

Work from Office

Duties and Responsibilities Market Analytics in identifying trends in industry, market insights, competition mapping Leading sales for LATAM team, handle direct Key accounts across the globe Quantitative & Qualitative Analysis, Customer Management

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1.0 - 3.0 years

2 - 3 Lacs

Gurugram

Work from Office

Evolet Healthcare Pvt. Ltd. is seeking a highly motivated and talented individual to join our team as Executive-IBD. Role & responsibilities Analyze Dynamics/Demographics, Language. (Market size, Growth, GDP, Saturation, Regulatory review, Competitor Profiling) Analyze Local Manufacturing companies in a Specific country Maintaining, updating, and recording contact details such as email/ telephone communication in the Client Database file (EPD) Daily Monitoring EPD for tracking follow-ups with companies Generate a Monthly analysis Report of EPD and discuss with HOD for further actions Introductory email to fresh companies Studying existing tools to identify EPD companies, and adding more tools by continuous research for new partners Analyze Export Data - extracting a list of Importers and further searching on contact details/emails/telephone for EPD Analyze Google search - extracting a list of importers with complete contact details for EPD Analyze MOH to get a list of Importers via the website or by finding RLS Analyze Exhibitions for a published list of Importers/International visitors (past/current IPHEX, CPHI, etc.) Analyze possibilities with Embassies to get a list of Importers via email/calls/visits Analyze Online Pharmacies' websites to extract importers, to prepare the online pharma database to analyze prices of products in the future Emails - Introduction emails, follow-up emails, review emails, and timely response to EPD Companies Calls - cold calls to new companies, follow-ups RLS complete Profiling and regular updates (Monthly) [Registrations List] Additional Skills: Good knowledge of Export documentation. The candidate must have experience in setting up Pharmaceutical Formulations Export business in LATAM (OSD and Injectable) and other ROW markets. Must have connections with distributors in various countries to be able to establish an export business. Thorough knowledge of Formulations (OSD Oral Solids (Tablets, Capsules), Syrups, Sachets & Injectables. Requirements: Bachelor's degree in B.Pharma, B.Com, B.A 1-3 years of relevant experience in international business development or related roles. Proficiency in English and Spanish languages (both spoken and written) is essential. Perks: Health Insurance Shuttle facility, Fix office timing, Career growth training & development

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4.0 - 9.0 years

5 - 14 Lacs

Pune

Work from Office

Looking for International Business / Sales / BD / EXPORT Manager / Sr Manager for PHARMACEUTICALS EXPORTS. (B2B) Person will be responsible for Export / International Marketing / Sales for Pharma Formulation for EU, ROW Markets. Various Countries Location-Pune Corporate Office (S. B. ROAD - SHIVAJI NAGAR, PUNE ). This is a Office Based Job (Pune), Profile : Handle Current Export Business Clients smoothly Co-ordination with client and factory for timely delivery of goods.Coordinate with Regulatory Department to ensure proper dossier submission and getting MA. Required Candidate profile Good Communications Skills Honest, Hard Working Growth Mindset (Important) Ambitious & Positive Thinker 5-12 years of experience in Pharma Formulation Exports. Proficient English Writing / Speaking (Mandatory) Computer proficiency in MS Office, Excel, e-mail and internet functions PLEASE APPLY WITH PROPER COVERING NOTE at info@vekocare.com . We are fastest growing company in India, & have vacancies across different areas in Pharmaceutical Manufacturing / Sales operation. Even Junior Candidates with relevant exposure can contact us .

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11.0 - 17.0 years

9 - 13 Lacs

Ahmedabad

Work from Office

Role & responsibilities Job Title: International Regulatory Affairs (IRA) Sr. Manager Location: Ahmedabad -HO Markets: CIS (Including EAEU), LATAM (Central and South America), Middle East, Africa, South East Asia. Key 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. Preferred candidate profile

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7.0 - 12.0 years

6 - 8 Lacs

Ahmedabad

Work from Office

1.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 and CIS , ROW Countries and other country as per company requirements. 2.Responsible for final review of dossier before submission. 3.To coordinate with technical team for documents required for dossier. 4.Responsible to gather data related for dossier through online sources, laboratories, manufactures etc. 5.Reviewing artwork for products as per relevant regulatory authority requirements. 6.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; 7.Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. 8.Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. 9. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. 10. Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives. .

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4.0 - 9.0 years

5 - 12 Lacs

Hyderabad/Secunderabad

Work from Office

Roles and Responsibilities Should Have Formulation Experience. Having vacancies in RoW (ASIA , MENA, LATAM, AFRICA) Regions Responsible for product registration RoW (ASIA , MENA, LATAM, AFRICA) Regions region Preparation, compilation and review of dossiers for region in eCTD/CTD/country specific format. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. Responding to queries with in the time lines received from client/agency. Preparation of check list as per country specific requirements region. Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in MENA region. Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration. Archiving/Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base. Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency. Filing of variations if any and registration renewals. Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments. Maintaining the product status (Registered and Under registration) in excel sheet. Desired Candidate Profile Should Have Regulatory Affairs Relevant Formulation Experience Perks and Benefits

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2.0 - 7.0 years

5 - 10 Lacs

Gurugram

Work from Office

Responsibilities: * For International Market only * From pharmaceutical Background only *B2B * Collaborate with cross-functional teams on product launches & marketing strategies * Manage international sales pipeline from lead generation to closure

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8.0 - 12.0 years

10 - 13 Lacs

Ahmedabad

Work from Office

Role & responsibilities Develop and implement regulatory strategies to support research projects and product development initiatives. Monitor and interpret regulatory requirements and guidelines related to scientific research, including USFDA, Europe (EMA), UKMHRA, Canada (Health Canada), Brazil (ANVISA), China (NMPA), Australia (TGA), New Zealand (MMDSA) Japan (PMDA) and other relevant international standards. Prepare and submit regulatory filing agency queries with gap analysis, including API DMFs, eCTD details, and other relevant documents, ensuring accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to integrate regulatory considerations into project timelines and deliverables. Conduct regulatory reviews of research protocols, study reports, and other scientific documents to ensure compliance with regulatory requirements. Communicate with regulatory agencies as necessary to facilitate approvals, responses to inquiries, and other regulatory interactions. Maintain current knowledge of regulatory landscape changes and provide updates and training to internal stakeholders as needed. Participate in internal and external audits and inspections related to regulatory compliance. Demonstrated understanding of regulatory requirements and guidelines relevant to scientific research, including experience with reference listed product confirmation Qualifications Bachelors degree in a science, pharmacy, or a related field; advanced degree (e.g., Masters, PhD) preferred. Minimum of 8- 12 years of experience in regulatory affairs within a research environment, preferably in a Pharmaceutical, Biotechnology industry. Skills Strong organizational skills and attention to detail with the ability to manage multiple priorities in a fast-paced environment. Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams. Ability to independently solve problems and make decisions, exercising good judgment in ambiguous situations.

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17.0 - 27.0 years

27 - 42 Lacs

Nagpur

Work from Office

Job Summary: We are looking for an experienced and strategic Regulatory Affairs leader to head our Regulatory function. The ideal candidate will oversee all regulatory submission activities, ensure timely approvals, maintain compliance with evolving global health authority requirements, and provide expert regulatory guidance for new and existing pharmaceutical products across ROW & regulated markets. Key Responsibilities Regulatory Strategy & Compliance: • Coordinate with agents, partners, and MOHs to define submission strategies. • Prepare internal strategy documents and lead regulatory discussions for new products. Dossier Management & Submissions: • Manage CTD/ACTD/eCTD submissions for new registrations, renewals, and variations. • Ensure dossiers and query responses are complete and compliant. • Coordinate with plants for registration samples and related documentation. Stakeholder Collaboration: • Work with internal teams and external partners to gather and finalize technical documents. Regulatory Operations Oversight: • Compile and submit responses to MOH/partner queries on time. • Track regulatory submissions as per calendar. • Oversee renewals of FDA licenses, WHO GMP, COPPs, etc. Training & Regulatory Intelligence: • Conduct training on updated guidelines. • Share critical regulatory updates with teams. Documentation & Reporting: • Review technical and administrative dossier sections. • Maintain monthly regulatory status reports. • Coordinate site registrations and pre-audit activities. Leadership & Team Development: • Guide the RA team for efficiency and compliance. • Promote process improvements and regulatory best practices. • Handle additional tasks under the RA function. neetij@selectsourceintl.com

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8.0 - 13.0 years

15 - 27 Lacs

Pune

Remote

Job Title: Senior SAP ABAP Developer S/4HANA (LATAM Rollout Focus) About the Role: We are seeking a highly skilled Senior SAP ABAP Developer to support the expansion of our global S/4HANA 1909 template into the Latin America region. This role will play a key part in developing scalable, high-performance solutions tailored to the fintech industry, integrating localized requirements within a harmonized global framework. The ideal candidate will bring deep expertise in modern SAP development tools, including ABAP on HANA, CDS Views, OData, and SAP BTP. Key Responsibilities: • Design and build scalable, performance-optimized ABAP programs for S/4HANA, aligned with global template standards. • Develop and maintain CDS Views and OData services for SAP Fiori apps and external system integrations. • Integrate SAP S/4HANA with SAP BTP services and third-party systems to support end-to-end business processes. • Collaborate with functional consultants and regional teams to deliver localized enhancements for Brazil, Mexico, Colombia, and Panama. • Analyze and tune custom code performance in HANA-based environments. • Implement reusable components and enforce code quality, security, and maintainability standards. • Contribute to system upgrade and migration activities, ensuring development compatibility. • Prepare technical specifications and conduct peer reviews and knowledgesharing sessions. Required Qualifications & Skills: • 8+ years of hands-on SAP ABAP development experience, including ABAP on HANA (CDS, AMDP, performance optimization). • Strong experience with Object-Oriented ABAP and SAP enhancement techniques. • Deep knowledge of OData service development and consumption. • Experience with SAP Business Technology Platform (BTP), especially integration with S/4HANA. • Familiarity with SAP Fiori/UI5 development, extensions, and launchpad configuration. • Proven experience designing and maintaining SAP workflows (classic/BWF). • Participation in S/4HANA implementation or rollout projects (greenfield or brownfield). • Understanding of SAP Cloud Connector, authentication, and security models. • Strong analytical, debugging, and performance-tuning skills. • Ability to work independently in a fast-paced, multinational environment. Preferred Skills: • Exposure to SAP Integration Suite (API Management, Cloud Integration), BRF+, and SAP Analytics Cloud. • Understanding of DevOps concepts, CI/CD pipelines for SAP, and SAP Gitenabled Change and Transport System (gCTS). • Experience working within Agile/Scrum frameworks. • SAP Certification(s) in ABAP, S/4HANA Development, or BTP.

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2.0 - 5.0 years

1 - 5 Lacs

Vadodara

Work from Office

Executive to Sr Executive-International Business development Region specific experience of South East Asia. Years of experience- 2 to 5 years in Pharma formulation Industry

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