Senior Manager, US Regulatory Affairs - Wellness

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question. 

About the role  

The Senior Manager, US Regulatory Affairs-Wellness is responsible for end-to-end regulatory activities for the Wellness portfolio, which is comprised of primarily dietary supplements.  Involves execution of well-constructed regulatory strategies that keep pace with the dynamic supplement and food regulatory environment.  Builds strong relationships with all stakeholders, internal and external. Provides leadership to cross-functional teams, such as product development, medical, legal and marketing, as well as in regulatory.

Role Responsibilities

• Develop and implement regulatory strategies and documents for new product launches and maintenance of current products in the market with the correct alignment and compliance to regulations

• Manage compliance within defined portfolio/activity streams in line with Haleon expectations

• Support key processes and ways of working (eg, product labeling requirements, quality, local regulations)

• Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated.

• Provide development, coaching and mentorship to the Wellness regulatory team

• Collaborate with stakeholders (commercial, product develeopment, etc.) to ensure regulatory contributions achieve the objectives in the strategy, achieve agreed standards, to maximize overall project delivery time and POS

• Proactively identify potential risks and manage impact of regulatory changes within defined scope of responsibility on the business

• Maintain high level of knowledge on the science of products & ingredients within the portfolio

• Review and approve artwork for dietary supplements

• Work together with regulatory colleagues and other stakeholders (e.g. marketing, medical, legal)  to proactively look for opportunities and solutions to challenges, including leading implementation of improvement initiatives

External Engagement:

• Monitor regulatory trends that could impact the portfolio, identify & report impact of business.

• Active participant externally in industry association activities, ensuring that Haleon POV is considered.   

Business Expertise 

• Proven knowledge of the competitive and regulatory landscape for dietary supplements, and how to apply that knowledge when assessing new product opportunities, ingredients and claims. 

Problem Solving 

• This role will independently sit on project teams.  The regulatory environment for dietary supplements 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 supplement regulations.   

Nature & Area of Impact  

• This role is primarily internally facing.   Because this role largely deals with regulatory compliance, impact can be broad within the US business.   Strong organizational skills with out-of-the-box thinking a must.

Why you? 

Basic Qualifications: 

• BA or BSc in a Life Science (such as Nutrition, Food Science Biology, Chemistry)

• 7+ years of experience with Regulatory Affairs

• 5+ years working specifically in US dietary supplements, or combination of 5 + years experience in dietary supplements and Food/Medical Food

• Proficient knowledge in regulations and oversight of dietary supplements and experience with lifecycle management activities

• Expertise in DSHEA and Dietary Ingredient qualifications (i.e. GRAS, ODI, NDI, etc)

• Excellent communications skills, stakeholder management and enjoys working in multidisciplinary teams

• Ability to manage prioritize projects of high complexity

• Experience