Post for a Regulatory Affairs Manager - Biologicals @ Biocon - 5 Openings
Biocon is a research-driven, global healthcare company with a strong matrix of capabilities along the biopharmaceutical value chain. Focusing on unmet medical needs in cancer, diabetes and inflammatory diseases, it offers novel therapies on a platform of affordable innovation.
Biocon together with group companies employs more than 2500 employees with approxmimately Rs 1,000 crore turnover and is expected to grow further during the current financial year.
Post: Regulatory Affairs Manager - Biologicals
To ensure the filing of required regulatory documents on time as per regulatory norms, take active participation from start of the project and give Regulatory strategy inputs to the team.
Liaise with Regulatory agencies, partners, customers, agents.
Lead a team dedicated for a project and be a part of any Regulatory inspection.
Play an important role in any decision making.
Review of Dossiers, regulatory documents, response to deficiencies and guide team members.
Ensuring Good Regulatory Practices are followed within the team and also proper training is provided amongst the team members.
Perform Gap analysis
Strong knowledge and experience in handling regulatory requirements, functions with Biologicals particularly with filing with USFDA and EU for the final marketing approval (NDA, ANDA)
Handling of ROW markets and with knowledge on non-clinical, clinical and BA/BE studies with Labeling requirements, electronic submission would be an added value.
Ability to evaluate weakness and provide training and develop strategies to strengthen the weaker skills in the team.
Experience: 9-12 Years
Education: B.Pharm, M.Pharm, B.Sc, M.Sc-Chemistry
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
End Date: 30th August, 2011
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