Head of Regulatory Strategy

Head of Regulatory Strategy

About the Company

A specialty pharmaceutical company based in the San Francisco Bay Area

Industry
Pharmaceuticals

Type
Privately Held

About the Role

The Company is seeking a Head of Regulatory Strategy to take on a senior leadership role with a focus on owning and driving global regulatory strategy across development programs. This high-impact, hands-on position involves leading the regulatory strategy from early development to post-approval, preparing NDA/BLA submissions in eCTD format, and engaging in face-to-face meetings with health authorities. The successful candidate will be responsible for developing regulatory risk assessments, mitigation strategies, and supporting market access, as well as maintaining regulatory documentation across programs. Applicants for the Head of Regulatory Strategy role at the company should have an advanced degree (PharmD, PhD, or MD) and a minimum of 12 years' experience in regulatory affairs within the pharmaceutical or biotech industry. The role requires a candidate with a strong background in NDA or BLA approval, particularly with hands-on experience, and a proven track record of strong interactions with the FDA. Global regulatory knowledge is essential, and the position demands a professional who is adept at leading and preparing for regulatory submissions and meetings. The ideal candidate will be a scientist at heart, with a passion for the intersection of science and regulatory affairs, and will be expected to work closely with senior leadership and health authorities.

Travel Percent
Less than 10%

Functions

• Strategy