Charak Pharma Pvt. Ltd., a leading name in Ayurvedic and herbal pharmaceutical formulations, is hiring an experienced Regulatory Affairs Manager - Export to independently lead end-to-end export regulatory activities across international markets. The ideal candidate brings 8-10 years of hands-on experience in pharmaceutical export regulatory affairs, strong command of CTD/ACTD dossier preparation, and a proven ability to manage product registrations and drive approvals with overseas regulatory authorities and international buyers.

Key Responsibilities:

- Independently handle end-to-end export regulatory affairs activities for pharmaceutical, Ayurvedic, herbal and nutraceutical products.

- Manage product registrations, re-registrations, renewals, product variations and complete lifecycle management across export markets.

- Prepare, compile, review and submit CTD/ACTD dossiers and all associated regulatory documentation.

- Serve as the front-line contact for international buyers on regulatory documentation and product registration matters.

- Arrange registration samples and all supporting documents required for submissions.

- Handle regulatory queries and prepare deficiency responses within committed timelines.

- Follow up with international customers and regulatory authorities until approvals are received.

- Coordinate with QA, QC, Manufacturing, R&D; and other internal departments to gather regulatory requirements.

- Coordinate and support manufacturing site inspections/audits by overseas regulatory authorities and customers.





- Study and interpret regulatory guidelines of existing and new export markets.

- Evaluate new countries and shortlist products suitable for registration based on country-specific regulations.

- Maintain complete, audit-ready regulatory documentation and the registration database.

Required Skills and Competencies:

- 8-10 years of dedicated experience in Export Regulatory Affairs within the pharmaceutical industry.

- Strong, independent expertise in CTD/ACTD dossier preparation, compilation and submission.

- Proven track record in product registration, re-registration, renewals and variations across international markets.

- Working knowledge of country-specific regulatory guidelines for ROW, semi-regulated and emerging markets.

- Excellent written and verbal communication for direct interaction with international buyers and regulatory authorities.

- Ability to handle deficiency and query responses and drive registrations to approval.

- Solid cross-functional coordination skills across QA, QC, R&D; and Manufacturing.

- High attention to detail, documentation discipline and database management.

Preferred Candidate Profile:

- Education: B.Pharm and/or M.Pharm preferred; M.Sc in Life Sciences, Chemistry or Biotechnology also considered.

- Prior experience in Ayurvedic, herbal or nutraceutical product registration is a strong advantage.

- Experience handling multiple export geographies independently.

- Self-motivated, able to own regulatory timelines end-to-end with minimal supervision.

- Based in Mumbai.

📌 Regulatory Affairs Manager (Mumbai)
🏢 Charak Pharma
📍 Mumbai