Manager, Regulatory Affairs - OTC

Welcome to Haleon. Were a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, weve 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 its 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 Manager, Regulatory Affairs - OTC role is accountable for end-to-end execution of regulatory activities at the product and project level for the diverse US OTC portfolio (monograph, NDA products, medical device). The role owns regulatory strategy execution for assigned products or initiatives, ensuring alignment with the broader portfolio strategy and execution that keeps pace with the dynamic regulatory environment and evolving consumer healthcare space.

Provides cross-functional leadership within project teams, operating as the regulatory lead for defined projects, while escalating complex risks and strategic decisions as appropriate.

Role Responsibilities

Regulatory Strategy & Execution

• Develop regulatory strategies for assigned projects, aligned to portfolio-level direction

• Translate regulatory strategy into actionable project plans with defined milestones

• Lead end-to-end execution of regulatory project plans, managing timelines, dependencies, deliverables

• Manage cross-functional contributors to ensure timely submission and approvals

• Identify risks and proactively escalate complex issues

• Independently author routine regulatory submissions (e.g. annual reports)

• Directly engage with FDA to address routine/straight forward matters

• Complete compliance related activities within defined portfolio

• Contribute to process improvements and implementation of regulatory best practices

• Help develop and deliver labeling for assigned products, ensuring alignment with business objectives and compliance with US regulations

• Conduct regulatory review of advertising and promotional materials for assigned products, to deliver substantiated, compelling claims.

Leadership & Influence

• Provide matrix leadership within cross-functional teams

• Mentor junior staff informally

• Contribute to building regulatory capability within the team

• Monitor regulatory changes and assess impact at product/project level

• Active participant externally in industry association activities, ensuring that Haleon POV is considered.

Problem Solving

• This role will independently sit on project teams. The OTC regulatory environment is complex and dynamic. This role must be able to navigate ambiguous regulatory scenarios and be able to provide balanced and actionable. Must know how to leverage and interpret regulatory precedent, and other external information to Agency regulations.

Nature & Area of Impact

• This role is primarily internally 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:

• Bachelors Degree in Pharmaceutical or Life Sciences, Chemistry, Biology, Medicine, or similar discipline

• 47 years regulatory experience

• Experience supporting FDA submissions (OTC/NDA/CMC)

• Demonstrated ability to lead regulatory projects

• Excellent communications and organizational skills

• Collaborative and enjoys working in multidisciplinary teams

Preferred Qualifications:

• Advanced degree or professional certification

• Experience at a large global pharmaceutical or OTC CPG company

• Project management experience with strong organizational and prioritization skills

• 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.

Location : This role is hybrid based in Warren, NJ with in-office requirements of 3 times per week.

Compensation: The salary range for this role is: $122,621 - $168,603 plus an 12% on-target annual bonus.

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.

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. Its 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 Haleons compliance to all federal and state US Transparency requirements.

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 HR.AmericasSC-CS@haleon.com. 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.

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.