Vice President Regulatory Affairs at HAYS in Boston, Massachusetts

Job Description:

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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#1161109 - Joan Francesc Garcia