Senior Director US Regulatory Affairs
$259,842–$357,280 year
Hybrid · Warren Township, New Jersey, United States
Job Summary
Senior Director, Regulatory Affairs leads the US OTC regulatory strategy and policy for the portfolio, shaping category-level direction across regulatory affairs, lifecycle management, and growth initiatives. The role requires influencing external authorities and internal stakeholders, driving end-to-end regulatory activities, and building team capability through coaching and governance frameworks. Responsibilities include developing and implementing regulatory strategies for innovation, lifecycle management, and growth opportunities; guiding governance across the OTC portfolio; leading complex FDA interactions and negotiations; driving operational excellence in regulatory deliverables; and embedding automation and analytics into regulatory processes to enable real-time tracking and decision-making. The position also entails strategic leadership to align regulatory programs with enterprise objectives, engage with industry associations, and oversee performance measures and reporting across programs.
Required Qualifications
- Bachelor’s Degree in Pharmaceutical or Life Sciences, Chemistry, Biology, Medicine, or similar discipline
- 12 or more years of experience in regulatory affairs
- Experience with OTC monograph and NDA regulatory frameworks; Rx-to-OTC switch strategy and execution; and complex FDA interactions and negotiations
- Strong communications and stakeholder management skills
- Proven leadership of high-performing teams and capability development
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