Senior Manager, Regulatory Affairs - OTC

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. 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).

Responsibilities

• Regulatory Strategy & Execution
• Help shape the portfolio by devloping 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 that Haleon POV 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
• Nature & Area of Impact
• 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.
• Why you?

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
• 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 organizati

Benefits

Additional Information

Welcome to Haleon. We're a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we've grown, evolved and are now entering an exciting new chapter - one filled with bold ambitions and enormous opportunity. Our trusted portfolio of brands - including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® - lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science. Now it's time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose - to deliver better everyday health with humanity - at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture.

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