Senior Manager, Regulatory Affairs - OTC

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 Manager, Regulatory Affairs - OTC role is accountable for end-to-end regulatory activities for the OTC Category, owning and defending the full brand-level regulatory strategy for assigned products (monograph/NDA drug, medical devices).This role is responsible for prioritization, resource alignment, and delivery at pace across multiple projects or initiatives within a portfolio. This role requires building strong relationships with internal and external stakeholders; strategic regulatory decision-making and execution of more complex projects; leadership of cross funtional team and Health Authority interactions, and developing regulatory talent (with or without formal line management responsibilities).Role Responsibilities Regulatory Strategy & ExecutionHelp shape the portfolio by devloping and executing regulatory strategies for assigned products / programsOwn and defend regulatory strategy across a portfolio or brandTranslate portfolio strategy into actionable plans with concrete deliverablesLead end-to-end execution of regulatory project plans (timelines, dependencies, deliverables)Ensure alignment across multiple initiatives; adjust based on evolving risks/business needsManage cross-functional contributors to ensure timely submission and approvalsConduct portfolio-level risk assessment and mitigation planningIndependently author regulatory submissions (e.g. NDAs, supplements, briefing documents, responses)Lead interactions with FDA, including responses to Agency queriesManage compliance within defined portfolio/activity streams in line with Haleon expectationsDrive continuous improvement and operational excellence through implementation of regulatory best practicesDefine labeling strategy and approach across assigned brands/portfolio.Set direction on claims substantiation and promotional compliance.Leadership & InfluenceBuild team capability by developing, coaching and mentoring staffInterpret regulatory trends and proactively shape business strategyActive participant externally in industry association activities, ensuring that Haleon POV is considered. Business Expertise Proven knowledge of the competitive and regulatory landscape for OTC Drugs, and how to apply that knowledge when assessing new product opportunities. Problem Solving This role will independently sit on project teams. 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. 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 discipline7 to 10 years of experience in regulatory affairsExperience working on FDA applications, OTC monograph products, chemistry, manufacturing and controlsProficient knowledge in US FDA regulationsExcellent communications skills, stakeholder management and enjoys working in multidisciplinary teamsAbility to manage prioritize projects of high complexityExperience leading end-to-end regulatory process in new product launchesDemonstrated ability to lead projects or cross-functional teamsPreferred Qualifications: Advanced degree in Pharmacy, Chemistry, Biology, Medicine, or similar disciplineExperience at a large global pharmaceutical or OTC CPG companyExperience building strong relationships and collaboration, managing trusted stakeholder relationships internally and externallyExperience communicating with FDA (including FDA meetings, briefing books, and responses to Regulatory Agency questions)Project management experience with strong organizational and prioritization skillsGrowth Mindset, with a love of learning and focus on what is possibleBias for Action and comfort with fast paceInterest 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: $152,620 - $209,852 plus an 18% on-target annual bonus.BenefitsHaleon 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 Date2026-08-28Equal OpportunitiesHaleon 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 RequestsIf 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 View email address on click.appcast.io. 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 candidatesThe 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.SummaryLocation: USA - New Jersey - WarrenType: Full time