Regulatory Affairs Executive – International Business (Third-Party Manufacturing & Exports)
Job Summary
Responsible for managing regulatory affairs activities for Finished Dosage Formulations (FDF) manufactured through third-party/contract manufacturing partners and marketed under the company's own brands in international markets. The role involves dossier compilation, product registrations, lifecycle management, coordination with manufacturers and regulatory authorities, and ensuring compliance with country-specific regulatory requirements to support business growth across export markets.
Key Responsibilities
Regulatory Submissions & Product Registrations
- Prepare, review, compile, and submit registration dossiers for products manufactured by third-party manufacturers and exported under the company's brand.
- Manage new registrations, renewals, variations, amendments, and re-registrations across international markets.
- Coordinate responses to regulatory queries and deficiency letters within stipulated timelines.
- Maintain registration trackers and ensure timely approvals to support market launches.
Third-Party Manufacturer Coordination
- Liaise with contract manufacturers to obtain regulatory documents, technical data, stability studies, specifications, validation documents, GMP certificates, and other supporting information.
- Review manufacturer documentation to ensure compliance with importing country requirements.
- Coordinate change control activities and assess regulatory impact arising from manufacturing, formulation, packaging, or site changes.
Regulatory Compliance & Documentation
- Ensure dossiers and supporting documents comply with WHO, ICH, and country-specific regulatory requirements.
- Maintain and update regulatory databases, product dossiers, licenses, approvals, and registration records.
- Monitor registration validity and initiate renewals proactively.
Cross-Functional & Business Support
- Work closely with International Business, Sourcing, QA, Supply Chain, and Packaging teams to ensure timely product registrations and launches.
- Support evaluation of new products and new markets from a regulatory feasibility perspective.
- Coordinate with overseas distributors, agents, consultants, and health authorities regarding registration activities.
Artwork & Lifecycle Management
- Review and approve product artworks, labels, inserts, and packaging materials as per market regulations.
- Manage post-approval variations, renewals, and maintenance of product registrations throughout the product lifecycle.
- Track changes in international regulations and communicate their impact to internal stakeholders.
Qualifications & Experience
- B.Pharm / M.Pharm or equivalent qualification in Pharmaceutical Sciences.
- 2–5 years of experience in International Regulatory Affairs within a pharmaceutical export organization.
- Experience handling dossiers and registrations for products manufactured through third-party/contract manufacturing arrangements.
- Exposure to semi-regulated and emerging markets (Africa, Asia, CIS, LATAM, Middle East) preferred.
Required Skills
- Strong knowledge of CTD/eCTD dossier compilation and international registration processes.
- Understanding of WHO-GMP, ICH guidelines, CPP, FSC, GMP certifications, and export regulatory documentation.
- Ability to coordinate effectively with third-party manufacturers and international partners.
- Strong documentation, analytical, and project management skills.
- Proficiency in Microsoft Office, particularly Excel and Word.
- Excellent communication and follow-up skills.
Key Performance Indicators (KPIs)
- Timely submission and approval of product registrations.
- Registration success rate across assigned markets.
- Closure of regulatory queries within agreed timelines.
- On-time renewals and lifecycle management activities.
- Accuracy and completeness of regulatory dossiers.
- Successful support for new product launches and market expansions.
Employment Type: Full-Time | Based in: Kochi | Send your resume to [email protected]
Job Types: Full-time, Permanent, Fresher
Pay: ₹25,000.00 - ₹35,000.00 per month
Benefits:
- Health insurance
- Paid time off
- Provident Fund
Experience:
- Pharmaceutical : 1 year (Required)
Location:
- Kochi, Kerala (Preferred)
Work Location: In person
