Senior Director US Regulatory Affairs

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.

About the role  

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.

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

  • 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 

• The regulatory environment for OTC drugs is complex and dynamic.   This role must be able to navigate ambiguous regulatory scenarios and be able to provide balanced advice in a manner that can be acted on by commercial teams and senior leadership.   Must know how to leverage and interpret regulatory precedent, and other external information to Agency regulations.   

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? 

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.

Location: This role is based in Warren, New Jersey, and follows a hybrid model, requiring an in-office presence of 3 days per week.

Compensation: The salary range for this role is: $259,842 - $357,28 plus a 30% on-target bonus and Long-Term Incentive award.

#Li-Hybrid

Benefits

Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program.  This includes a generous 401(k) plan, tuition reimbursement and time off programs including 6 months paid parental leave.  On day one, you are eligible for benefits, including our healthcare programs where the company pays for the majority of your medical coverage for you and your family.  We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs as part of the offering.

Job Posting End Date

 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. It guides us in creating an inclusive culture, where different backgrounds and views are valued and respected – all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. It’s important to us that Haleon is a place where all our employees feel they truly belong.

During the application process, we may ask you to share some personal information, which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development, refinement, and execution of our inclusion and belonging programmes that are open to all Haleon employees. 

The personal information you provide will be kept confidential, used only for legitimate business purposes, and will never be used in making any employment decisions, including hiring decisions.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.

Accommodation Requests

If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please contact us by sending an email to [email protected]. Please include the following in your email: 

Use subject line: ‘Haleon Careers: Job Accommodation Request’ 

Your Name and contact information 

Requisition ID and Job Title you are interested in 

Location of Requisition (city/state or province/country) 

Description of specific accommodation you are requesting 

Please note: Resumes, CVs, or other requests outside of accommodation support submitted to this email box will not be accepted.

Note to candidates

The Haleon recruitment team will contact you using a Haleon email account (@haleon.com). If you are not sure whether the email you received is from Haleon, please get in touch.