Senior Manager, Regulatory Affairs - OTC

Haleon • Warren Township, NJ

19h • $152,620 - $209,852 • Hybrid

About The Position

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).

Requirements

• 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 communications skills, stakeholder management and enjoys working in multidisciplinary teams
• Ability to manage prioritize projects of high complexity
• Experience leading end-to-end regulatory process in new product launches
• Demonstrated ability to lead projects or cross-functional teams

Nice To Haves

• 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 FDA meetings, briefing books, and responses to Regulatory Agency questions)
• 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

• 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
• Active participant 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.
• 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.
• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager