Manager - Regulatory Affairs

Job Profile requirement for Regulatory managerial level position

Candidate should have 8-12 years of experience.

1. Candidate should able to handle independently regulatory activities of Emerging Markets.

2. Candidate would be responsible for product registrations and for overall regulatory activities, operations & strategy for new filings, renewals, variations, etc. and their submissions. Submission of dossiers. Rigorous follow-ups and coordinating closely with MOH / FDA/LTRs of respective countries once the dossiers are submitted through Sales Team /distributor.

3. Candidate would be responsible for ensuring all submissions comply with current regional regulations. Ensure compliance with GMP, ICH, WHO and country-specific regulations.

4. Review, preparation, compilation of dossiers of Tablets, Capsules, Injection, Dry powder

Injectable, ophthalmic, Suspension, Syrup, Creams and Ointments in CTD/ACTD to regulatory authorities, as per current global regulatory guidelines for Marketing authorization. Corrections, amendments and submission of new & renewal registration dossiers for Africa, Latam, MENA, CIS and Asean countries.

5. Candidate should be able to maintain product registrations throughout product life cycle, ensure timely renewals, Track variation implementation & support post-approval commitments

6. Candidate should be able to coordinate communication with Contract manufacturing sites & Health Authorities through local partners.

7. Candidate should support inspections and regulatory audits.

8. Candidate would be responsible for monitoring regulatory changes across assigned markets. Communicate new regulations to internal stakeholders and assess impact of regulatory changes.

9. Candidate should review product labels, package inserts and artworks. Ensure labeling complies with country regulations and coordinate implementation of approved labeling changes.

10. Ensure effective & prompt (timely) attention and handling of various queries and regulatory issues, received from the customers, regulatory bodies, ministry of health (MOH) and related authorities.

11. Candidate should ensure proper systems of archiving and retrieving of data for ready reference for smooth, timesaving and effective functioning of registration department.

12. Tender Documentation: - All the Technical and other documents preparation, review, compilation and submission.

13. Candidate should be able to do additional responsibilities like Export Orders updates, Status of registration, Samples status, CoPP, Export Certificates, Free Sale Certificates, Export license copy, GMP Certificates (including notarization and/or attestation from various embassies), as per registration requirements, courier details, booking of Couriers, bills and other related routine queries & regulatory activities.