Are you ready for your next step? We've been engaged with a Biotech/Pharmaceutical Company in Boston for a VP
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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