Senior Associate, Regulatory Affairs

About the Role Senior Associate, Regulatory Affairs responsible for independent execution of regulatory activities for defined products, workstreams, or deliverables within the US OTC portfolio. Acts as a specialist in regulatory processes and systems supporting cross‑brand delivery across the US OTC portfolio. Ensures efficient, compliant execution of submissions, labeling, and maintenance activities while leveraging regulatory systems, tools, and standardized processes. Role Responsibilities Deliver routine regulatory activities for assigned products or workstreams. Analyze regulations, precedent, and product‑specific considerations to contribute to development of regulatory strategies. Translate strategic direction into execution of defined deliverables. Track deliverables, communicate progress, and elevate issues to ensure timely execution. Provide operational expertise and cross‑brand support for regulatory systems, tools, and processes. Execute activities within regulatory information management systems (RIMS) and document systems. Maintain regulatory records, databases, and trackers to ensure data accuracy, completeness, and inspection readiness. Identify and implement process improvements or standardizations. Operate as an independent contributor on project teams and may provide informal mentorship or guidance to junior associates. Build strong cross‑functional relationships within assigned teams. Basic Qualifications Bachelor’s Degree in Pharmaceutical or Life Sciences, Chemistry, Biology, Medicine, or a related discipline. 2–4 years of regulatory experience. Strong understanding of US FDA regulatory frameworks. Experience supporting regulatory submissions (OTC, NDA, or related). Excellent communication skills, stakeholder management, and enjoyment of working in multidisciplinary teams. Preferred Qualifications Advanced degree or professional certification. Experience working within cross‑functional project teams. Demonstrated ability to manage multiple deliverables independently. Growth mindset, love of learning, and focus on what is possible. Bias for action and comfort with a 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 requirement three times per week. Compensation Salary range: $87,575 – $120,415 plus an 8% on‑target annual bonus. Benefits Haleon offers a robust total reward package including a generous 401(k) plan, tuition reimbursement, paid parental leave, and comprehensive health coverage. Employees also have access to discretionary bonuses based on key business performance and other incentive/recognition programs. Equal Opportunities Haleon is committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. We create an inclusive culture where different backgrounds and views are valued and respected, supporting the best service to our consumers. The information you provide in the application process will be kept confidential and used only for legitimate business purposes, and never in making any employment decisions, including hiring. If you’re a US licensed healthcare professional, we may capture and report expenses in compliance with federal and state transparency requirements. #J-18808-Ljbffr