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Company Name : Roche
Location : Mumbai, Maharashtra
Position : Partner – 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
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.
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