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 Michelle@juntoHLS.com.