Manager, Regulatory Affairs - OTC

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 a diverse US OTC portfolio (monograph, NDA products, medical device). The role owns regulatory strategy execution, ensuring alignment with portfolio strategy and adapting to the dynamic regulatory environment. Responsibilities Regulatory Strategy & Execution Develop regulatory strategies for assigned projects aligned to portfolio-level direction Translate strategy into actionable project plans with defined milestones Lead end-to-end execution of project plans, managing timelines, dependencies, and deliverables Manage cross‑functional contributors to ensure timely submission and approvals Identify risks and proactively escalates 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 the defined portfolio Contribute to process improvements and implementation of regulatory best practices Help develop and deliver labeling for assigned products, ensuring business objectives and US regulatory compliance Conduct regulatory review of advertising and promotional materials for assigned products, ensuring substantiated, compliant 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 Actively participate externally in industry association activities, ensuring Haleon POV is considered Problem Solving Independently sit on project teams to navigate ambiguous regulatory scenarios, providing balanced and actionable guidance Leverage and interpret regulatory precedent, external information, and agency regulations to inform decisions Nature & Area of Impact Primarily internally facing with broad impact within the US business, requiring strong organizational skills and innovative thinking Basic Qualifications Bachelor’s Degree in Pharmaceutical or Life Sciences, Chemistry, Biology, Medicine, or similar discipline 4–7 years regulatory experience Experience supporting FDA submissions (OTC/NDA/CMC) Demonstrated ability to lead regulatory projects Excellent communication 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, love of learning, and focus on possibilities 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 Hybrid based in Warren, NJ with in‑office requirements of 3 times per week. Compensation Salary range: $122,621 – $168,603 plus a 12% on‑target annual bonus. Benefits Haleon offers a robust Total Reward package that includes competitive pay, a comprehensive benefits program, a generous 401(k) plan, tuition reimbursement, and paid parental leave. On day one, employees are eligible for benefits, including healthcare programs with majority coverage paid by the company. Additional discretionary bonuses may be awarded based on key business performance. Equal Opportunities Haleon is committed to mobilising its purpose in a way that represents diverse consumers and communities. The company fosters an inclusive culture where varied backgrounds and viewpoints are valued and respected, ensuring that all employees feel they belong. All hiring decisions are non‑discriminatory and comply with applicable laws. #J-18808-Ljbffr Haleon plc.