Vice President of Global Regulatory Affairs

HIRING: Vice President of Global Regulatory Affairs - Growing Global Biotech - California

Hays Life Sciences is exclusively retained by a rapidly growing global biotechnology company to assist in their search for a Vice President, Global Regulatory Affairs to be based in California (San Francisco Bay Area). The story of the company’s origins is very unique and makes them a compelling company to join. This Oncology-focused company is at a critical stage of development as they have only recently progressed to phase III trials for their lead product. The Vice President, Global Regulatory Affairs will be an integral part of the company’s management team, responsible for building a Regulatory Affairs department. As such, this is a highly visible role and will be a vital addition to the organization.

In this capacity, you will be responsible for the development and implementation of global regulatory strategies with the goal of securing product approvals across the globe. You will provide management, oversight and leadership for the Regulatory Affairs department internally and externally. You will serve as the primary Regulatory Affairs point of contact for the company with the FDA and global health authorities. You will manage and oversee all operational aspects of regulatory submissions including INDs, NDAs, BLAs and PMAs. In addition, you will be providing regulatory guidance throughout the clinical trial process as well as building and growing the Regulatory Affairs department.

At minimum, you must possess a Bachelor’s degree in a life sciences related discipline, 10+ years of Regulatory Affairs pharmaceutical industry experience, biologics experience and clinical trial and drug development experience. Advanced degree (Ph.D. or Master’s) is ideal. RAC certification is a bonus. Prior experience with people management is a must.

Apply now for consideration.


Job type:
Full Time
Life Sciences
Competitive / Based on Experience
Apply Now

Talk to a consultant

Talk to Tanya Saker, the specialist consultant managing this position, located in New York City

16th Floor, 200 West 41st St, New York, New York, NY 10036

Telephone: 9175257860

Share Job