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Haleon Hong Kong5 days ago

Senior Director US Regulatory Affairs

$259,842–$357,280 year

Hybrid · Warren Township, New Jersey, United States

Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Enterprise

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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$260k – $357k / yr

Senior Director US Regulatory Affairs · Haleon Hong Kong

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