Job Details

Head of Regulatory StrategyAbout the CompanySpecialty pharmaceutical company driving global regulatory strategy across development programs.IndustryPharmaceuticalsTypePrivately HeldAbout the RoleThe 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 in a relevant field (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 ideal candidate will be a scientist at heart, passionate about the intersection of science and regulatory affairs. The position demands a professional who is adept at leading and preparing for regulatory submissions, as well as developing and implementing regulatory strategies to ensure the success of the company's programs.Travel PercentLess than 10%FunctionsStrategy