Assoc Dir/Sr Mgr, Global Regulatory Affairs CMC Biologics

Junto HLS has been exclusively engaged by a Top 20 Pharma client to recruit an Associate Director/ Senior Manager, Global Regulatory Affairs CMC Biologics.

Position Overview:  

  • Develops and leads the execution of regulatory CMC development and registration strategies as the RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams for assigned products throughout clinical development and commercial lifecycle
  • Develops and applies a comprehensive understanding of global RA CMC regulations and guidelines to projects  to enhance probability of regulatory success and regulatory compliance
  • Manages interactions with local and international Health Authorities, successfully negotiating RA CMC matters, directly and indirectly
  • Develop constructive relations with key internal and external colleagues, including Alliance Partners
  • Plans, executes and manages regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities with minimal supervision
  • Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements
  • Evaluates change proposals for regulatory impact and filing requirements

Location(s):

  • Greater Boston Area, MA

If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to Michelle@juntoHLS.com.