Dr. Reddy’s Laboratories Ltd is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products Dr. Reddy™s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Major therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management and anti-infective.
Hiring for 2 Regulatory affairs Associates /specialists with 2-10 yrs exp. range for Dr.Reddy’s Biologics Business, Hyderabad, INDIA. (Hybrid work).
(Preferable from organizations working on mAbs / Biosimilars / Biologics).
Roles & expected expertise:
1. Dossier finalisation (drafting, compilation and finalisation);
2. Filing regulatory applications (Licenses, Toxicity studies, clinical studies, marketing authorisations, compliance notifications);
3. Internal laisoning for compilation of regulatory information for dossiers and query responses
4. Co-ordination with Qaulity assurance teams during audits
5. Regulatory compliance and systems
Applications and References can be mailed across ”[email protected]”
