I've recently been engaged with a Biotech Company, and I'm recruiting for a VP, 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 Chief Medical Officer 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 Trials

• 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.

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.

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