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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