Regulatory Affairs Manager / Sr. Manager


A specialty biotech has engaged Junto HLS on a Regulatory Affairs Manager / Sr. Manager position. The position may reside in Colorado, North Carolina or New Jersey.

Are you a fit for the position?

  • Regulatory Affairs Strategy/Project Management Experience
  • Ability to work effectively with cross-functional departments
  • Strong verbal and written communication skills
  • Oncology experience a plus (but not required)
  • (See Select Accountabilities below)

Select Accountabilities: Regulatory Affairs Manager / Sr. Manager

  • Responsible for the preparation of regulatory submissions in compliance with global requirements (strategy/PM)
    • Manage team reviews of regulatory submissions
    • Work closely with Regulatory Operations to ensure submissions are well planned and meet current standards
  • Participate in group meetings and provide status updates and strategic input on moderately complex aspects of the development programs
  • Support meetings with Regulatory Authorities
  • Maintain up-to-date knowledge of regulatory requirements and communicate in a timely manner any updates that may impact the development programs


  • Colorado/ North Carolina/ New Jersey

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