Manager Global Regulatory Affairs

1 month ago

bangalore, India Biocon Biologics Full time

Regulatory Affairs Manager

Bangalore, India


Job Description:

  • Hands on experience on drug substance manufacturing process, designing and executing process characterization studies (upstream, downstream, formulation) as well as process comparability for biologics (monoclonal antibodies/growth factors/hormones)
  • Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products.
  • 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
  • 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


Mandatory/Required Skill:

  • Hands on experience on drug substance manufacturing process, designing and executing process characterization studies (upstream, downstream, formulation) and process comparability for biologics (monoclonal antibodies/growth factors/hormones) is mandatory for this role.
  • Please do not apply if you do not have hands on experience in drug substance manufacturing process, designing and executing process characterization studies.

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