Company Description

At Dr. Reddy's "Good Health Can't Wait"

By joining Dr. Reddy’s, you will contribute to making the breakthroughs of tomorrow a reality today From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking energetic and energetic individuals ready to inspire, ready to make a difference for their community and every community.

Diversity, Equity & Inclusion

At Dr. Reddy’s, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background.

Job Description

We seek to hire an Associate Regulatory Affairs to support our North America business. This role will be based in person in Hyderabad and is an 8-month temporary assignment to provide maternity leave coverage.



The incumbent will carry out core regulatory activities including Authoring, compilation, and publishing of regulatory submissions and independently supporting the life cycle management activities for the externally manufactured products (Dr. Reddy’s and in-licensed products) and ensuring regulatory compliance and systems.
Responsibilities
- Authoring, compilation, and publishing of regulatory submissions inclusive of chemistry, manufacturing and controls supplements, new drug applications and generic drugs as assigned.
- Provide regulatory operational support for External Manufacturing operations including co-ordination with CMOs, obtaining required documents from different CMOs, change controls and master document reviews, regulatory submissions.
- Compilation of post approval Changes (Supplements PAS/CBE-30/CBE-0 & Annual Reports) for ANDAs managed by North America Generics (NAG).
- Authoring of Annual Reports of the drug products and

📌 Associate Regulatory Affairs (Hyderabad)
🏢 Dr. Reddy's Laboratories
📍 Hyderabad