Manager Global Regulatory Affairs

4 weeks 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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