Cmc Regulatory Manager in Weybridge

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 The Portfolio Protection and Optimisation Chemistry, Manufacturing, and Controls (\’xBP\’ CMC) regulatory team is co-located in UK and India and collaborates with global stakeholders on key programmes that impact Haleon\’s product portfolio.
Your role will identify and analyse the impact of evolving CMC requirements and guidance affecting the Haleon portfolio and to translate these into actionable insights, ensuring our products are brought into compliance with evolving requirements and updated health authority guidance.
Effective communication is essential and external advocacy may be required.
You will be expected to propose and justify regulatory strategies, assess regulatory risks, to work within project teams to mitigate and deliver regulatory packages to enable optimisation of manufacturing operations at our sites.
Key responsibilities Prepare and deliver all CMC regulatory inputs for complex programmes, managing impact assessments, regulatory strategy development, risk management and creation of submission components covering a range of product families and business units.
Analyse regulatory issues and evaluate impact of emerging changes to regulatory requirements or guidance.
Work with stakeholders to develop plans to mitigate and ensure products are compliant.
Provide clear regulatory advice, ensuring senior management and cross-functional teams are informed of current CMC requirements and emerging trends.
Working in partnership with other functions, prepare briefing books, position papers, justifications, responses to requests for further information from regulatory authorities and support advocacy actions, proactively presenting Haleon\’s policies and strategies and reinforcing our trusted science.
Build relationships with key stakeholders and represent Haleon in an appropriate manner according to company values.
Contribute to process improvement initiatives, supporting ways of working and contributing to the activity of a high performing team, including looking for ways to improve performance.
Qualifications and skills Essential ·BA or BSc or equivalent in a Pharmaceutical-related science (e.g. Chemistry, Pharmacy, Pharmaceutical Sciences, Biochemistry, Biology, Medical Engineering), or equivalent experience ·1-2 years industry experience in regulatory affairs including preparing CMC submissions for new products or variations with a good knowledge of dossier requirements.
·5+ years over-the-counter (OTC) medicinal product experience in R