Senior Director US Regulatory Affairs

Senior Director, Regulatory Affairs Location: Warren, New Jersey — hybrid model with 3 days per week in-office. About the Role Senior Director, Regulatory Affairs serves as Head of US Regulatory OTC Category. The role defines and leads regulatory strategy across the US OTC portfolio, including innovation, Rx-to-OTC switch, and inorganic growth opportunities. As a senior member of the Regulatory Leadership Team, this position sets regulatory direction at the category level, ensures alignment with enterprise objectives, and influences internal and external stakeholders to shape regulatory strategy, policy, and outcomes. The role operates with broad decision authority, integrating scientific, regulatory, and commercial considerations to drive sustained growth, innovation, and compliance across the OTC business. Role Responsibilities Regulatory Strategy & Execution Define and govern regulatory strategy across the OTC portfolio by: Developing category‑level regulatory strategy covering innovation, lifecycle, and growth initiatives Establishing regulatory position and policy framework across OTC portfolio Delivering clear strategic guidance aligned to enterprise and business objectives Champion a growth‑oriented regulatory mindset by developing and advancing novel, fit‑for‑purpose regulatory strategies to unlock new innovation opportunities. Drive operational excellence, efficiency & pace by: Implementing structured project management frameworks, tools, and templates to improve predictability, speed, and quality of regulatory deliverables Driving end‑to‑end visibility of regulatory activities, timelines, and dependencies across projects and portfolios Optimizing resource utilization through prioritization, workload balancing, and proactive risk identification Leadership & Influence Defined engagement strategies for complex regulatory programs Lead complex, high‑impact regulatory interactions Establish credibility and influence with external stakeholders and authorities Build regulatory team capability through structured coaching, targeted skill development, and ongoing performance management Active leadership in industry associations and policy‑shaping initiatives People & Capability Development Embed a culture of accountability, planning discipline, and execution excellence within the regulatory organization Promote consistent application of lessons learned and best practices across programs Implement standardized tools, processes, and governance frameworks to drive visibility and alignment across projects Leverage digital tools, dashboards, and regulatory systems to enable real‑time tracking and reporting of regulatory activities Identify opportunities to integrate automation, AI, or analytics into regulatory project workflows Business Acumen Proven knowledge of the competitive and regulatory landscape for OTC Drugs, and how to apply that knowledge when assessing new product opportunities; integrate regulatory into business decision‑making and investment prioritization Problem Solving Navigate complex and dynamic regulatory environments, providing balanced advice that can be acted on by commercial teams and senior leadership; leverage and interpret regulatory precedent and external information to Agency regulations Nature & Area of Impact Role is both internally and externally facing with broad impact within the US business; requires strong organizational skills and out‑of‑the‑box thinking Basic Qualifications Bachelor’s Degree in Pharmaceutical or Life Sciences, Chemistry, Biology, Medicine, or similar discipline 12 or more years of experience in regulatory affairs Demonstrated experience setting and defending regulatory strategy at portfolio or category level Extensive experience with OTC monograph and NDA regulatory frameworks; Rx-to-OTC switch strategy and execution; and complex FDA interactions and negotiations Proven track record of external influence and regulatory advocacy Experience leading high‑performing teams and organizational capability development Excellent communications and stakeholder management skills Preferred Qualifications Advanced degree in Pharmacy, Chemistry, Biology, Medicine, or similar discipline Experience at a large global pharmaceutical or OTC CPG company Growth mindset, with a love of learning and focus on what is possible Bias for action and comfort with fast pace Interest and capability in applying AI and digital tools to modernize regulatory processes and improve efficiency Experience with implementing change initiatives and leading change Sustaining energy and well‑being, building resilience in teams Translating strategy into action – a compelling narrative, motivating others, setting objectives and delegation Strategic thinking including setting and implementing a clear vision and direction, big picture enterprise thinking while maintaining ability to execute successfully Compensation The salary range for this role is: $259,842 - $357,28 plus a 30% on‑target bonus and Long‑Term Incentive award. Benefits Competitive 401(k) plan with employer match Tuition reimbursement Paid parental leave (6 months) Healthcare programs with majority employer coverage for you and family Discretionary bonus based on key business performance and other incentive/recognition programs Equal Opportunities Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. We create an inclusive culture where different backgrounds and views are valued and respected. It’s important to us that Haleon is a place where all employees feel they truly belong. We invite all interested candidates to apply. Job Posting End Date: 2026-06-25. #J-18808-Ljbffr