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

Location(s):

• 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 Michelle@juntoHLS.com.