Senior Manager, Regulatory Affairs - OTC

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. 

With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we’re uniquely placed to do this and to grow a strong, successful business.  

This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special. 

About the role  

This Senior Manager, Regulatory Affairs - OTC has responsibility for end-to-end regulatory activities for the OTC portfolio, which is comprised primarily of OTC drugs under the Monograph and New Drug Applications. Involves execution of well-constructed regulatory strategies that keep pace with the dynamic 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

• Ensures cross portfolio aligned regulatory strategy to deliver timely approvals for US submissions and OTC Monograph product launches.

• Develop and implement regulatory strategies and documents for new product launches and maintenance of current products aligned with the regulations.

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

• Provides advice on US-specific activities and ways of working, processes as mentor or coach; provides support, as needed, for meetings/teleconferences with US regulatory agency

• Prepares registration files, briefing books, supplements, annual report files, and responses to Regulatory Agency questions  

• Interacts with regulatory agencies to answer questions regarding submissions.  

• Develops and applies the knowledge of current labeling requirements to the creation, review and approval of product labels

• Participates in the review of promotional materials

• Ensures quality and process improvements within US and provides cross portfolio resources support as appropriate

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

• Develop up-to-date knowledge of regulatory requirements, as well as technical trends 

• Work with regulatory colleagues and other stakeholders to proactively look for opportunities and solutions to challenges, including leading implementation of improvement initiatives

• Provide development, coaching and mentorship to the regulatory team

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.   

Other Responsibilities  

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 

• This role will independently sit on project teams.  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.   Must know how to leverage and interpret regulatory precedent, and other external information to Agency regulations.   

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