Regulatory Affairs Manager

Job Description

1. Co-ordination with QA, QC, R&D, manufacturing, and other stakeholders to collect submission documents.

2. Ensure the adequacy, completeness, and compliance of all documents received from cross-functional teams

3. Review regulatory dossiers in CTD/eCTD/ACTD/Country specific checklist in accordance with global health authority requirements.

4. Review responses to regulatory queries from global health authorities and business partners for accuracy and compliance.

5. Ensure timely updates in Regulatory Information Management Systems (RIMS), including submission records, deficiency tracking, document archiving, and dossier trackers.

6. Define strategies for responding effectively to regulatory deficiencies and queries. Review responses prepared for regulatory authority queries to ensure scientific accuracy and regulatory compliance.

7. Review approval packages.

8. Review and approve change controls and assess their regulatory impact across global markets.

9. Review documentation related to renewals, variations, and post-approval changes as part of product lifecycle management activities.

10. Ensure timely submission of samples required for registration purposes across different markets.

11. Review necessary documents for GMP applications, including site-related submissions where applicable.

12. Ensure timely processing of agency invoices and regulatory-related payments.

13. Review national submission and translation activities by coordinating with local consultants and translators following DCP approval.

14. Generate GDUFA cover sheets for ANDA fees, Facility Fees, and Program Fees, and coordinate agency, partner, and consultant payments.

15. Support the preparation and review of Scientific Advice Meeting and Pre-ANDA meeting packages.

16. Perform additional duties and responsibilities assigned by department leadership to support regulatory operations and business objectives.