Cadila Pharmaceuticals Ltd., one of India’s most respected and innovation-driven pharmaceutical companies, is expanding its Regulatory Affairs team. We are inviting skilled professionals to join us as a Research Associate (Regulatory Affairs) at our Dholka (Ahmedabad) location.
Position: Research Associate – Regulatory Affairs
Experience Required: Minimum 3 years
Key Responsibilities
As a Research Associate in Regulatory Affairs, you will play a critical role in ensuring regulatory compliance and supporting global submissions. Your responsibilities will include:
Preparation, review, and submission of Drug Master Files (DMFs) for regulated & semi-regulated markets.
Submission of DMF updates, annual reports, and responses to global regulatory authorities (US, Canada, China, Korea) using eCTD/CTD formats.
Preparation and query handling for EDQM submissions via CESP in eCTD format.
Development of closed-part DMFs for non-regulated markets.
Drafting of customer responses for international markets.
Evaluation of processes & synthesis routes to ensure regulatory compliance.
Compilation and review of regulatory submissions and technical documents.
Review of STPs, change controls, AMV, impurity profiles, and drug substance characterization.
Preparation of LOAs, CEP LOAs, declarations, and regulatory guidelines.
Verification of current pharmacopoeial monographs during DMF filing.
Why Join Cadila Pharmaceuticals?
Work with one of the largest privately-held pharmaceutical companies in India.
Be part of a dynamic team driving regulatory excellence in global markets.
Opportunity to work on diverse regulatory submissions across regulated and semi-regulated markets.
How to Apply
If you have the required experience and are eager to grow your career in Regulatory Affairs, we’d love to hear from you.
Send your updated resume to:
disha.bhalani@cadilapharma.com
Join Cadila Pharmaceuticals and make a difference in shaping the future of global healthcare.
