Associate Director, Global Regulatory Affairs CMC Biologics

Junto HLS has been engaged by Sr. Leadership at a growing, mid-cap pharma to recruit an Associate Director, Global Regulatory Affairs CMC Biologics.

Position Overview:

  • Responsible for managing and leading registration and CMC regulatory support for commercial and development projects worldwide.
  • Planning, writing and reviewing Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents). Manage the internal review and submission of these items.
  • Participate as an active member of a multi-disciplinary team to establish development of Regulatory CMC strategies for commercial products, late, and early stage development programs. Identify and communicate potential risks associated with strategy scenarios.
  • Manage EU, US, International commercial license maintenance.
  • Provide in-depth reviews of protocols, reports, presentations, and documents.
  • Manage CMC related regulatory agency interactions.
  • Coordinate the preparation and timely submission of responses to regulatory agencies. Manage timelines to ensure approvals are timely and development objectives are met.
  • Act as primary regulatory CMC representative at internal meetings as well as support at meetings with business partners and regulatory agencies for CMC related issues.
  • Monitor Global CMC regulations, and assess any changes to ensure all development activities are in compliance with applicable current regulations and guidelines.
  • Ensure continued regulatory compliance of products though change control procedure.
  • Participate in the quality verification of regulatory submissions.
  • Provide risk assessments and recommendations for various regulatory scenarios.


    • Philadelphia, PA

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