Biocon Biologics at Chennai is a 56000 sq. ft RND centre equipped with end-to-end cutting-edge infrastructure involving upstream, downstream, formulation, analytical characterization, functional characterization, and pilot facilities. A world-class team is being put together to develop biosimilar therapies all the way through process development, characterization, scale-up, and technology transfer to feed into our large-scale manufacturing facilities at Bangalore.
Department : Global Regulatory Affairs
Experience : If you are BTech / MSc / M.Pharm / MTech or Equivalent with biologies background and experience in regulatory affairs/ MSAT (Mfg Science and Technology)/ Process QA, with experience range of 5 to 15 years for any or all of the below-mentioned skill sets
Job Description
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.
Job Location : Bengaluru
Interested candidates are requested to email their resume to nived.desai@biocon.com
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