CMC Regulatory Manager

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&D (e.g. formulation development), quality control/testing laboratory, manufacturing or packaging environment.

·Strategic thinking and business awareness.

Preferred

·MSc or TOPRA/RAPS certification would be advantage, but not essential.

·Experience in preparing Regulatory CMC submissions for products in multiple markets, covering end-to-end life cycle management.

·Expert technical knowledge in an area such as formulation development, manufacturing/packaging operations, analytical laboratory.

·Ability to communicate complex issues to stakeholders and teams.

·Negotiation skills and an ability to interact across teams and at all levels.

·Experience in monitoring the external regulatory environment and in advocacy activities is desirable.  

 Job Posting End Date

Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture, where different backgrounds and views are valued and respected – all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. It’s important to us that Haleon is a place where all our employees feel they truly belong.
During the application process, we may ask you to share some personal information, which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development, refinement, and execution of our inclusion and belonging programmes that are open to all Haleon employees. 
The personal information you provide will be kept confidential, used only for legitimate business purposes, and will never be used in making any employment decisions, including hiring decisions.

If you require a reasonable adjustment or accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific adjustments you are requesting. We’ll provide all reasonable adjustments to support you throughout the recruitment process and treat all information you provide us in confidence. 

The Haleon recruitment team will contact you using a Haleon email account (@haleon.com). If you are not sure whether the email you received is from Haleon, please get in touch.