Director/ Associate Director, Regulatory Affairs CMC

Junto HLS has been engaged by Sr. Leadership at a Bay Area biotech to recruit a Director/ Associate Director, Regulatory Affairs CMC.

Position Overview:

  • Biologics experience preferred.
  • Must have BS/BA in life sciences or equivalent; advanced degree preferred.
  • Excellent interpersonal and communication skills.
  • Works with Senior Leadership to develop CMC regulatory strategies for biopharmaceutical products in development.
  • Represents RA at project team meetings and coordinates workflow between departments as well as CROs.
  • Responsible for interactions with regulatory authorities as needed.
  • Coordinate all CMC aspects of global regulatory submissions.
  • Participates in department initiatives to improve standards and systems internally and maintain relationships with other departments including consultants and vendors.

Location(s):

    • Greater San Francisco Bay Area, CA

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