Strategic Regulatory Compliance Specialist

1 week ago


Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 90,00,000 - ₹ 1,20,00,000

We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our team.

Key Responsibilities
  • 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.
  • Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration.
  • Ensure and lead regulatory compliance for biosimilar products.
  • Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products.
  • Escalate regulatory issues, progress, and metrics to the Biosimilars function.
Knowledge and Skills
  • Comprehensive understanding of Regulatory activities.
  • Experienced in analytical method development, method validation, method transfers and characterization of biologic products. Regulatory experience with product filings.
  • Ability to understand and communicate scientific CMC information.
  • Able to anticipate and prevent potential issues.
  • Ability to communicate regulatory strategies and requirements to ensure expectations are understood.


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