Roche Pharmaceuticals, India, has been disseminating scientific knowledge pertaining to innovative medicines to the medical fraternity. We have products in therapeutic areas such as Oncology, Virology, Nephrology, Transplantation, Anemia and Rheumatoid Arthritis. In recognition of its contributions in Oncology, Roche India has been awarded the Best Oncology Company of the Year, by Frost & Sullivan at the India Healthcare Excellence Awards for the years 2011, 2012 and 2014.
Post : Assistant Manager - Regulatory Affairs
Job Description
Maintain high level of Regulatory Compliance to ensure life-cycle management of existing product & accelerate access to Roche innovations in line with the strategic objectives that will enable achieving Roche India 2030 vision by ensuring faster regulatory approvals
• Responsible to obtain accelerated regulatory approvals of new drug products & therapies/line extensions to provide access of our innovative medicines to Indian patients.
• Responsible for licenses maintenance and regulatory compliance for established drug products to ensure uninterrupted supplies to the patients.
• Responsible to ensure accelerated clinical trial approvals are obtained for local data generation to aid new drug approvals.
• Contribute in regulatory policy related matters (directly and through industry organization) to foster regulatory environment in the country that supports accelerated access of our innovations to the patients
• Gather, analyse and communicate internal and external regulatory intelligence
• Provide regulatory expertise and input into cross-functional Affiliate business strategies (e.g. market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, legal issues, etc.)
• Develop innovative, risk-based registration plans and submissions strategies for Affiliate products with limited guidance from DRA Management
• Represent Affiliate Regulatory in cross-functional teams
Additional Information
Qualification : M.Pharm, M.Sc
Location : Maharashtra, Mumbai Bandra East
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 7th September, 2018
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