Regulatory Affairs Manager GB&I

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.

To manage a defined portfolio of products within the GB&I Regulatory Affairs Group to ensure proactive and timely compliance with all UK, Irish and European legislation and ensure that all regulatory activity is planned and geared to support and deliver commercial requirements. To identify and communicate regulatory issues which have the potential to affect the competitive impact of Consumer Healthcare products in the UK and Ireland.

Provision of an effective regulatory service to allow OTC medicines, medical devices, cosmetic products and food supplements to be legally sold in the UK and Ireland with strong claims which can be supported. To facilitate the launch of new cosmetic, medical device, medicinal and food supplement products, and to ensure that appropriate new Marketing Authorisations are obtained where necessary to allow continued and future sale of Consumer Healthcare products in GB&I (as relevant to portfolio).

To help ensure that regulatory activities are planned and geared to commercial requirements. To ensure all regulatory maintenance activity, pack copy and advertising for the GB&I business is managed to comply with the regulations and relevant company requirements.

Key Responsibilities:

• Responsible for ensuring that medicinal, medical device, cosmetic and food supplement products can be legally sold and supported in compliance with regulations.
• Provide advice, recommendations and support for product claims, copy and labelling.
• Responsible for ensuring that all personnel are given adequate training and guidance in all aspects of regulatory affairs work, and to ensure that all regulatory systems and databases are up to date and effectively managed.
• Ensures quality of both own and submission team work and compliance with regulatory guidelines and process within the required timelines.
• Responsible for the maintenance activities associated with a defined portfolio, including product renewals, and routine PV activity.
• Sets and resets priorities in rapidly changing circumstances and works with other team members to maintain focus and deliver objectives.
• Creates and maintains good working relationships within the Business and across Global Regulatory (GRA) functions, as well as other support functions, including factories and GMS teams, Quality, R&D, and with influential external bodies (Trade Associations and professional bodies).
• Leadership of, preparation and review of day to day submissions with full accountability for delivery.
• May also take accountability for larger projects as part of a broader project plan i.e. line extensions, global strategic projects, system changes etc.
• Contribute to the assessment of new innovation projects and exploratory product development briefs.
• Working either independently on Regulatory Strategy or with Category Regulatory Representatives, to help develop…