Regulatory Affairs Manager – FILLED
The Wellington Group has been engaged to find a Regulatory Affairs Managel for an exciting new position. This is a pivotal management role responsible for all activities of the Regulatory Affairs Department of this diverse, profitable pharmaceutical company.
The Regulatory Affairs Manager will oversee and manage all regulatory filings and obtain ANDA approvals and to ensure compliance with FDA regulations. This will include:
- Submitting quality submissions of ANDAs, AADAs, Supplements and Amendments
- Reviewing and submitting Annual Reports, Annual Drug Reviews, and Adverse Drug Experiences
- Interfacing with QA, NPD and manufacturing in data generation
- Interpreting regulations and supervising staff
The qualified Regulatory Affairs Manager candidate will have:
- BS degree in a scientific discipline
- 5+ years pharmaceutical, biologics or medical device experience
- 3+ years of FDA submissions experience
Industry: pharmaceutical, biotechnology, biologics, medical device
Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)