Role & responsibilities -

1. Review, preparation and finalize all CTD submissions for ROW/ EMERGING markets. Target to submit dossiers every month

2. Coordinate with R&D; for the registration of new formulations (Solids/Liquids/Creams)

3. Provide regulatory support to internal teams, global stakeholders, and external clients across multiple projects.

4. Develop regulatory strategies for recent product introductions and third-party vendor submissions.

5. Manage lifecycle activities including post-approval variations, renewals, and regulatory queries.

6. Collaborate cross-functionally with QA, QC, Packaging, and Production to ensure regulatory alignment.

7. Standardize and author SOPs, secured DMF/ASMF and BE/BA data, and support vendor qualification and training processes.

8. Liaison with local consultants and health authorities for faster approvals.

9. Conduct regulatory risk assessments for changes in manufacturing sites/vendors.

10. Oversee trademark filing and prosecution process, including coordination with external legal consultants and final approval of applications before submission.

11. Mentor and overlook daily technical output of Executives and Trainees.

📌 Job opportunity at Meyer Vitabiotics For Regulatory Affair Manager (Mumbai)
🏢 Meyer Organics
📍 Mumbai