Senior Strategic Relationship Manager

About the role

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. It requires building strong relationships with internal and external stakeholders; strategic regulatory decision-making and execution of more complex projects; leadership of cross-functional teams and Health Authority interactions; and developing regulatory talent (with or without formal line management responsibilities).

Responsibilities

• Regulatory Strategy & Execution
  • 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.
• Leadership & Influence
  • 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 Haleon’s point of view is considered.
• Business Expertise
  • Proven knowledge of the competitive and regulatory landscape for OTC Drugs, and how to apply that knowledge when assessing new product opportunities.
• Problem Solving
  • Navigate ambiguous regulatory scenarios and provide balanced advice that can be acted on by commercial teams.
  • Leverage and interpret regulatory precedent and other external information to Agency regulations.
• Nature & Area of Impact
  • Internally and externally facing role with broad impact within the US business.
  • Requires strong organizational skills and out-of-the-box thinking.

Qualifications

• Basic Qualifications
  • 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 enjoys working in multidisciplinary teams.
  • Ability to manage and prioritize projects of high complexity.
  • Experience leading end-to-end regulatory processes in new product launches.
  • Demonstrated ability to lead projects or cross-functional teams.
• Preferred Qualifications
  • 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 a fast pace.
  • Interest and capability in applying AI and digital tools to modernize regulatory processes and improve efficiency.

Schedule

This role is hybrid based in Warren, NJ with in-office requirements of 3 times per week.

Pay

The salary range for this role is $152,620 - $209,852 plus an 18% on-target annual bonus.

Benefits

• Robust Total Reward package including competitive pay and comprehensive benefits program.
• Generous 401(k) plan.
• Tuition reimbursement.
• Time off programs including 6 months paid parental leave.
• Eligible for benefits on day one, including healthcare programs where the company pays the majority of medical coverage for you and your family.
• Opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs.