Senior Director US Regulatory Affairs

Haleon • Warren Township, NJ

1d • $259,842 - $357,280 • Hybrid

About The Position

This Senior Director, Regulatory Affairs serves as Head, US Regulatory OTC Category. This role is accountable for defining and leading regulatory strategy across the US OTC portfolio, including organic innovation, Rx-to-OTC switch, and inorganic growth opportunities. As a senior member of the Regulatory Leadership Team, this position sets regulatory direction at the category level, ensures alignment with enterprise objectives, and influences internal and external stakeholders to shape regulatory strategy, policy, and outcomes. The role operates with broad decision authority, integrating scientific, regulatory, and commercial considerations to drive sustained growth, innovation, and compliance across the OTC business.

Requirements

• Bachelor’s Degree in Pharmaceutical or Life Sciences, Chemistry, Biology, Medicine, or similar discipline
• 12 or more years of experience in regulatory affairs
• Demonstrated experience setting and defending regulatory strategy at portfolio or category level
• Extensive experience with OTC monograph and NDA regulatory frameworks; Rx-to-OTC switch strategy and execution; and complex FDA interactions and negotiations
• Proven track record of external influence and regulatory advocacy
• Experience leading high-performing teams and organizational capability development
• Excellent communications and stakeholder management skills

Nice To Haves

• Advanced degree in Pharmacy, Chemistry, Biology, Medicine, or similar discipline
• Experience at a large global pharmaceutical or OTC CPG company
• 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.
• Experience with implementing change initiatives and leading change
• Sustaining energy and well-being, building resilience in teams
• Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation
• Strategic thinking including setting and implementing a clear vision and direction, big picture enterprise thinking while maintaining ability to execute successfully.

Responsibilities

• Define and govern regulatory strategy across the OTC portfolio by: Developing category-level regulatory strategy covering innovation, lifecycle, and growth initiatives Establishing regulatory position and policy framework across OTC portfolio Delivering clear strategic guidance aligned to enterprise and business objectives
• Champion a growth-oriented regulatory mindset by developing and advancing novel, fit-for-purpose regulatory strategies to unlock new innovation opportunities.
• Drive operational excellence, efficiency & pace Implement structured project management frameworks, tools, and templates to improve predictability, speed, and quality of regulatory deliverables Drive end-to-end visibility of regulatory activities, timelines, and dependencies across projects and portfolios Optimize resource utilization through prioritization, workload balancing, and proactive risk identification
• Defined engagement strategies for complex regulatory programs
• Lead complex, high-impact regulatory interactions
• Establish credibility and influence with external stakeholders and authorities
• Build regulatory team capability through structured coaching, targeted skill development, and ongoing performance management,
• Active leadership in industry associations and policy-shaping initiatives
• Embed a culture of accountability, planning discipline, and execution excellence within the regulatory organization
• Promote consistent application of lessons learned and best practices across programs
• Implement standardized tools, processes, and governance frameworks to drive visibility and alignment across projects
• Leverage digital tools, dashboards, and regulatory systems to enable real-time tracking and reporting of regulatory activities
• Identify opportunities to integrate automation, AI, or analytics into regulatory project workflows
• Proven knowledge of the competitive and regulatory landscape for OTC Drugs, and how to apply that knowledge when assessing new product opportunities.
• Integrate regulatory into business decision-making and investment prioritization
• 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 and senior leadership.
• 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

• generous 401(k) plan
• tuition reimbursement
• time off programs including 6 months paid parental leave
• healthcare programs where the company pays for the majority of your 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

What This Job Offers

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