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: Deputy Manager - National Regulatory Affairs
Leading and guiding the team members and imparting training to the team members to keep them abreast of the regulatory updates.
Providing strategic input and operational timelines into the project plans as a core member of the project team during the drug development process, clinical and general project forums/meetings and life cycle management projects.
Planning, execution, review and timely submission of reglatory documents for submissionto regulatory authorities for fresh/ renewal manufactuirng license, product permission, GMP, COPP, FSC and other relevant tender certificates.
Liasion with regulatory authorities for manufacturing license, product permission, GMP, COPP, FSC and other relevant tender certificate approvals
Maintain the registration certificate status and maintain the records of registered products for renewal of registration
Understanding of the Indian regulatory framework (Mianly State Licensing authorities) for Pharmaceutical and Biological Products
Excellent communication and organisation skills
Ability to work with different organisation levels and characters
Experience: 8-10 Years
Education: B.Pharm, M.Pharm, B.Sc, M.Sc - Chemistry
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
End Date: 27th Oct., 2011
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