Senior Associate, Regulatory Affairs
HaleonAbout the role
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.
About the Role
This Senior Associate, Regulatory Affairs role is responsible for independent execution of regulatory activities for defined products, workstreams, or deliverables within the US OTC portfolio.
This role will also serve as a specialist in regulatory processes and systems, supporting cross-brand delivery across the US OTC portfolio.
The position ensures efficient, compliant execution of submissions, labeling, and maintenance activities, while leveraging regulatory systems, tools, and standardized processes to enable innovation and sustain compliance.
The position contributes to regulatory strategy development while independently delivering assigned regulatory activities, ensuring compliance and timely execution. Operates with guidance on complex issues and escalates risks appropriately.
Role Responsibilities
Regulatory Execution
Deliver routine regulatory activities for assigned products or workstreams
Contribute to the development of regulatory strategies by analyzing regulations, precedent, and product-specific considerations
Translate strategic direction into execution of defined deliverables
Ensure timely execution of regulatory activities by tracking deliverables, communicating progress and escalating issues
Provide operational expertise and cross-brand support of regulatory systems, tools, and processes
Execute activities within regulatory information management systems (RIMS) and document systems
Maintain regulatory records, databases, and trackers to ensure data accuracy, completeness, and inspection readiness
Identifiy and implement process improvements or standardizations
Leadership & Influence
Operates as an independent contributor on project teams
May provide informal mentorship or guidance to junior associates
Builds strong cross-functional relationships within assigned teams
Nature & Area of Impact
This role is primarily internally 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?
Basic Qualifications:
Bachelor’s Degree in Pharmaceutical or Life Sciences, Chemistry, Biology, Medicine, or similar discipline
2–4 years regulatory experience
Strong understanding of US FDA regulatory frameworks
Experience supporting regulatory submissions (OTC, NDA, or related)
Excellent communications skills, stakeholder management and enjoys working in multidisciplinary teams
Preferred Qualifications:
Advanced degree or professional certification
Experience working within cross-functional project teams
Demonstrated ability to manage multiple deliverables independently
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.
Location: This role is hybrid based in Warren, NJ with in-office requirements of 3 times per week.
Compensation: The salary range for this role is: $87,575 - $120,415 plus an 8% on-target annual bonus.
Benefits
Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program. This includes a generous 401(k) plan, tuition reimbursemen
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