1. Leadership and strategic direction for DRA activities including development and implementation of regulatory strategies for product registration and lifecycle management

2. Prepare and review CTD, CTD, ACTD and country specific format dossiers for regulated, semi-regulated and emerging markets with keen emaphasis on CMC.

3. Life cycle management (filing annual updates, variations and amendments) of submitted dossiers including DMFs, CEPs and ASMFs as well as support to ANDAs and drug product dossiers.

4. Handling legal documentation for licensing of pharmaceutical products for export and domestic market as well as GMP, FSC and COPP concerning technical matters.
5. Specialized in response writing to Deficiency Letters in time bound manner from competent agencies and clients especially on CMC & quality related issues.

6. Maintain up-to-date customer documentation, including general declarations, statements, and query responses

7. Performing Internal Audit, Preparation of inspection reports, timely and effective closings of audit observations and non-compliance

Pay: ₹30,000.00 - ₹60,000.00 per month

Perks:

- Health insurance
- Leave encashment
- Paid sick time
- Provident Fund

Work Location: In person

📌 Regulatory Affairs Executive (India)
🏢 CHEMICAL RESOURCES
📍 India