Manager, Regulatory Affairs - OTC
About The Position
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.
Requirements
- 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 communications and organizational skills
- Collaborative and enjoys working in multidisciplinary teams
Nice To Haves
- 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.
Responsibilities
- 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.
- 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.
Benefits
- competitive pay
- comprehensive benefits program
- generous 401(k) plan
- tuition reimbursement
- time off programs
- 6 months paid parental leave
- healthcare programs where the company pays for the majority of your medical coverage for you and your family
- discretionary bonus based on the achievement of key business performance
- other incentive/recognition programs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
