Head of Regulatory Strategy

Head of Regulatory Strategy About the Company Ambitious pharmaceutical company 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 direct engagement with senior leadership and health authorities, leading global regulatory strategy from early development through post-approval, and preparing NDA/BLA submissions in eCTD format. The successful candidate will also be responsible for leading face-to-face meetings with regulatory agencies, developing regulatory risk assessments and mitigation strategies, and supporting market access while 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 FDA interactions. Global regulatory knowledge is essential, as is the ability to work in a dynamic, fast-paced environment. The ideal candidate will be a scientist at heart, with a passion for the intersection of science and regulatory affairs, and will be adept at developing and implementing regulatory strategies to support the company's development programs. Travel Percent Less than 10% Functions Strategy