Senior Director - US Regulatory Affairs (OTC)

4w4 weeks ago

Haleon

US · Full-time · $35,728 – $259,842

About this role

This Senior Director, Regulatory Affairs serves as Head, US Regulatory OTC Category at Haleon, a purpose-driven consumer health company behind brands like Sensodyne, Advil, and Centrum. The role is accountable for defining and leading regulatory strategy across the entire US OTC portfolio, including organic innovation, Rx-to-OTC switch, and inorganic growth opportunities.

Day-to-day, you will set regulatory direction at the category level, ensuring alignment with enterprise objectives while integrating scientific, regulatory, and commercial considerations. You will champion a growth-oriented regulatory mindset by developing novel, fit-for-purpose strategies to unlock new innovation opportunities and drive operational excellence through structured project management frameworks.

As a senior member of the Regulatory Leadership Team, you will influence internal and external stakeholders to shape regulatory strategy, policy, and outcomes. You will lead complex, high-impact regulatory interactions, establish credibility with authorities, and actively participate in industry associations and policy-shaping initiatives.

This role offers the opportunity to build regulatory team capability through structured coaching and skill development, embedding a culture of accountability and execution excellence. You will leverage digital tools and dashboards to enable real-time tracking and reporting, driving sustained growth and compliance across the OTC business.

Requirements

Proven experience leading regulatory strategy for OTC or consumer health products at a senior level
Deep understanding of FDA regulations and the Rx-to-OTC switch process
Ability to integrate scientific, regulatory, and commercial considerations to drive growth and compliance
Strong leadership and influence skills, with experience engaging external stakeholders and regulatory authorities
Demonstrated ability to develop and execute category-level regulatory strategies across a diverse portfolio
Experience implementing project management frameworks and driving operational excellence in regulatory affairs
Track record of building and developing high-performing regulatory teams through coaching and performance management

Responsibilities

Define and govern regulatory strategy across the OTC portfolio, including category-level strategy for innovation, lifecycle, and growth initiatives
Establish regulatory position and policy framework across the 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, and pace by implementing structured project management frameworks, tools, and templates
Lead complex, high-impact regulatory interactions and establish credibility with external stakeholders and authorities
Build regulatory team capability through structured coaching, targeted skill development, and ongoing performance management
Embed a culture of accountability, planning discipline, and execution excellence within the regulatory organization
Leverage digital tools, dashboards, and regulatory systems to enable real-time tracking and reporting of regulatory activities

Benefits

Opportunity to shape regulatory strategy for a world-class portfolio of trusted consumer health brands
Leadership role with broad decision authority and influence across the US OTC category
Access to digital tools and dashboards for real-time regulatory tracking and reporting
Culture of accountability, execution excellence, and continuous learning