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.