Manager Global Regulatory Affairs
4 weeks ago
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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