Manager Global Regulatory Affairs 20/06/2024

2 weeks ago

Bengaluru, Karnataka, India Biocon Biologics Full time
Manager - Global Regulatory Affairs

Bangalore, India

Job Summary:


Accountable for global CMC regulatory strategies with focus on analytical aspects for developmental/marketing submissions and Life Cycle Management for biosimilar products.


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
  • Ability to communicate regulatory strategies and requirements to ensure expectations are understood
  • Team skills, especially in working with internal and external partners
  • Familiarity with project management requirements
Knowledge and Skills

  • Comprehensive understanding of regulatory activities
  • In depth knowledge of analytical aspects of biosimilar development, protein characterization and analytical testing
  • Hands on experience of method development, qualification/validation, sample analysis
  • Ability to give critical inputs on study design for process change, method change, stability studies, bridging studies, outsourced studies etc as per relevant ICH guidelines
  • Ability to understand and communicate scientific CMC information
  • Anticipate and prevent potential issues

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