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Senior Manager Regulatory Affairs

2 months ago

Bengaluru, India Biocon Biologics Full time

Senior Manager – Global Regulatory Affairs

Location – Head-Office, Bangalore, IN

  • Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products.
  • 12+ years experience is mandatory


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


Regulatory Intelligence:

  • Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar products
  • Review and assess impact of regulatory decisions for competitive products
  • Generate and communicate biosimilar intelligence


Collaboration:

  • Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products
  • Identify process needs to meet internal challenges
  • Escalate regulatory issues, progress, and metrics to the GRA Biosimilars function


Knowledge and Skills

  • Comprehensive understanding of Regulatory activities
  • Regulatory experience with product filings
  • Team skills, especially in working with internal and external partners
  • Familiarity with project management requirements
  • Ability to understand and communicate scientific CMC information
  • Anticipate and prevent potential issues
  • Ability to communicate regulatory strategies and requirements to ensure expectations are understood