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 - 5 Posts
Job Description:
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
Candidate Profile:
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.
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Post: Regulatory Affairs Manager-Biologicals - 5 Posts
Job Description:
Interact with various departments/ teams to ensure filing of required regulatory documents on time as per regulatory norms.
Assist Sr.Manager/ Manager in the regulatory functions as required.
Assist/guide the subordinates in the team. Interact with customers, partners.
Responsible for compilation of Regulatory documents.
Ensuring Good Regulatory Practices are followed within the team and also proper training is provided amongst the team members.
Candidate Profile:
Strong knowledge about Biologicals and knowledge & experience in handling regulatory requirements of ROW markets and / or US, EU markets.
Dossier compilation (module 1-5)
Additional Information:
Experience: 9-12 Years for Regulatory Affairs Manager - Biologicals and 7-9 Years for Regulatory Affairs Deputy Manager - Biologicals
Location: Bangalore
Education: B.Pharm, M.Pharm, B.Sc, M.Sc-Chemistry
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
End Date: 28th Oct., 2011
Apply/Forward Your CV at, ramitha.ravindran@biocon.com
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