Biocon Biologics – Multiple Positions for Regulatory Affairs

Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases. Six molecules from Biocon Biologics’ portfolio have been taken from lab to market in developed markets like United States, EU, Australia, Canada and Japan. With a team of ~ 4,800 people, Biocon Biologics is committed to transforming healthcare and transforming lives by enabling affordable access to millions of patients’ worldwide.

Vacancy Details

Required Experience:

If you hold B.Tech/ MSc / M.Pharm / MTech degree or equivalent with a biologics background and experience in regulatory affairs/ MSAT (Mfg. Science & Technology) / Process QA, with experience range of 5-15 years for any or all of the below-mentioned skill-sets:

Department: Global Regulatory Affairs

1. Regulatory Life Cycle Management.
2. Core Dossier Preparation and Maintenance.
3. IND/ CTA/ BLA/MAA/NDA Submissions.
4. Regions – Advanced Markets (US, EU, Japan, Australia, Canada), Emerging Markets.
5. Regulatory response preparation, technical & scientific writing, compliance management etc.

Interested candidates are requested to email their resume to nived.desai@biocon.com