Senior Manager, Regulatory Affairs - OTC

Senior Manager, Regulatory Affairs – OTC

You will oversee end‑to‑end regulatory activities for the OTC category and manage the full brand‑level regulatory strategy for assigned products, including monograph/NDA drugs and medical devices. The role involves prioritising projects, aligning resources, leading cross‑functional teams, and engaging internal and external stakeholders.

• Help shape the portfolio by developing and executing regulatory strategies for assigned products/programs.
• Own and defend regulatory strategy across a portfolio or brand.
• Translate portfolio strategy into actionable plans with concrete deliverables.
• Lead end‑to‑end execution of regulatory project plans (timelines, dependencies, deliverables).
• Ensure alignment across multiple initiatives; adjust based on evolving risks/business needs.
• Manage cross‑functional contributors to ensure timely submission and approvals.
• Conduct portfolio‑level risk assessment and mitigation planning.
• Independently author regulatory submissions (e.g., NDAs, supplements, briefing documents, responses).
• Lead interactions with FDA, including responses to agency queries.
• Manage compliance within defined portfolio/activity streams in line with Haleon expectations.
• Drive continuous improvement and operational excellence through implementation of regulatory best practices.
• Define labeling strategy and approach across assigned brands/portfolio.
• Set direction on claims substantiation and promotional compliance.

• Build team capability by developing, coaching and mentoring staff.
• Interpret regulatory trends and proactively shape business strategy.
• Actively participate externally in industry association activities, ensuring that Haleon POV is considered.

• Proven knowledge of the competitive and regulatory landscape for OTC drugs, and how to apply that knowledge when assessing new product opportunities.

• Navigate complex and dynamic regulatory scenarios and provide balanced advice that can be acted on by commercial teams.
• Leverage and interpret regulatory precedent and external information to inform agency regulations.

• Internally and externally facing, with broad impact within the US business.
• Strong organisational skills and out‑of‑the‑box thinking required.

• Bachelor’s Degree in Pharmaceutical or Life Sciences, Chemistry, Biology, Medicine, or similar discipline.
• 7 to 10 years of experience in regulatory affairs.
• Experience working on FDA applications, OTC monograph products, chemistry, manufacturing and controls.
• Proficient knowledge in US FDA regulations.
• Excellent communication skills, stakeholder management, and enjoyment of multidisciplinary teamwork.
• Ability to manage and prioritise projects of high complexity.
• Experience leading end‑to‑end regulatory processes in new product launches.
• Demonstrated ability to lead projects or cross‑functional teams.

• Advanced degree in Pharmacy, Chemistry, Biology, Medicine, or similar discipline.
• Experience at a large global pharmaceutical or OTC CPG company.
• Experience building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
• Experience communicating with FDA (including meetings, briefing books, and responses to regulatory agency questions).
• Project management experience with strong organisational and prioritisation skills.
• Growth mindset, 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 modernise regulatory processes and improve efficiency.

Hybrid – based in Warren, NJ with in‑office requirements of 3 days per week.

Salary range: $152,620 – $209,852 plus an 18% on‑target annual bonus.

Haleon offers a comprehensive benefits program, including a generous 401(k) plan, tuition reimbursement, paid parental leave, healthcare coverage (majority paid by the company), and discretionary bonuses based on key business performance.

Haleon is 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, and where all employees feel they truly belong. During the application process, we may ask you to share personal information that is voluntary, used only for legitimate business purposes, and never for making employment decisions.