Sr Manager - Regulatory Affairs - Healthcare

Role : Lead, Strategize, plan, submit and ensure to get approvals/registration with the Indian regulatory authority and other emerging markets for Clinical trials, MAA, import of drugs, cosmetics and food supplements.

Major Responsibilities :

1. Strategize, plan, coordinate and execute submissions to ensure regulatory compliances and fast approvals for various dosage forms, food and cosmetics with the Indian authorities( DCGI) and emerging markets ( e.g.Nepal)

2. Evaluation and due diligence of inlicensing products for registration in India and other emerging markets.

3. Correspondence and Coordination with external agencies DCGI, NDAC, FSSAI, FDA for successful approvals.

4. Coordination with internal stakeholders to support the implement the regulatory strategies to ensure successful on times submissions.

5. Build relationship with the regulatory agencies and meet the regulatory expectation with respect to various concerns and developments at the regulatory front.

6. Handling of post submission activities: variations, updates and pharmaco-vigilance information to the regulatory agencies and Life cycle management for the Products

7. Review and Approve Routine quality systems activities on change controls and artwork.

8. Identify opportunities, develop systems and procedures to facilitate data collection, archival and retrieval at various fronts.

Contact at rupali.mumbai@omamconsultants.com