Manager Global Regulatory Affairs

2 months ago


Bengaluru, India Biocon Biologics Full time

Assistant Manager

Global Regulatory Affairs

Bangalore, India


Job Description:

  • Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products for emerging markets.
  • Biosimilars or injectables experience is mandatory for this role .


Responsible for :

  • Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio
  • Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products
  • Collaboration with partners to develop and execute global regulatory activities


Key Activities :

Regulatory Strategy and Execution

  • Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements
  • Provide regulatory direction on global regulatory requirements to support product development
  • Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle
  • Support development and execution of clinical/non-clinical strategies
  • Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration
  • Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans
  • With minimal supervision, participate in development of risk management and contingency planning
  • Ensure and lead regulatory compliance for biosimilar products
  • Participation in regulatory meetings with Health Authorities



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