This Senior Director, Regulatory Affairs serves as Head, US Regulatory OTC Category. This role is accountable for defining and leading regulatory strategy across the US OTC portfolio, including organic 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.
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
Implement structured project management frameworks, tools, and templates to improve predictability, speed, and quality of regulatory deliverables
Drive end-to-end visibility of regulatory activities, timelines, and dependencies across projects and portfolios
Optimize 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
Nature & Area of Impact
This role is both internally and externally facing. Because this role largely deals with regulatory strategy and compliance, impact can be broad within the US business. Strong organizational skills with out-of-the-box thinking is a must.
Why you?
Requirements
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
Benefits
Health insurance
Additional Information
Welcome to Haleon. We're a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we've grown, evolved and are now entering an exciting new chapter - one filled with bold ambitions and enormous opportunity.
Our trusted portfolio of brands - including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® - lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science.
Now it's time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose - to deliver better everyday health with humanity - at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture.
Gsknch · - New Jersey