Hays's recently been engaged with a Biotech Company for the search of a Vice President, Head of Regulatory Affairs in the Boston Area.
- Full time Role
- Role in the Boston Area. (Open to discuss if it's East Coast Based)
- Reporting to the CMO of the company.
Requirements: • Bachelor's degree in a scientific discipline; Graduate degree (Ph.D. or PharmD) strongly preferred • Minimum of 15 total years of progressive related experience in regulatory affairs in the pharmaceutical/biotech industry • Experience with designing and executing creative regulatory strategies for innovative products • Must have a solid understanding of FDA regulations and ICH guidelines, as well as comprehensive experience in the drug promotional and development processes • Experience preparing and overseeing regulatory submissions, including INDs/Clinical Trial • Experience with clinical trials and regulatory documentation is required • Experience with post-approval change management, comparability assessment, post-marketing commitments, and overall product life cycle management.
Please let me know if you'd be interested in having a conversation about the role.
Feel free to share your resume to joan.garcia@hays.com so we can schedule a videocall.