Vice President Regulatory Affairs

1161109
  • Job type

    Permanent
  • Location

    Boston
  • Profession

    Pharma
  • Industry

    Pharmaceuticals
  • Pay

    $315,000 - $360,000
  • Closing date

    3 Jul 2024

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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Talk to Joan Francesc Garcia, the specialist consultant managing this position

Located in New York City, 16th Floor, 200 West 41st StTelephone:  857 328 0334