DEPUTY MANAGER 7 views

Role Summary

Regulatory Affairs Biologics

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 requireme

Key Responsibilities

Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products.

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

nts

  • 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

Educational Qualifications

Required Education Qualification: M.Tech

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