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Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
People LeaderAll Job Posting Locations:
High Wycombe, Buckinghamshire, United KingdomJob Description:
Are you ready to make a difference?
At Johnson & Johnson, we are committed to addressing and solving some of the most meaningful unmet medical needs through creating an environment where our employees feel valued and can reach their potential. This commitment is embedded in our Credo!
The OpportunityAn exciting new opportunity has arisen for a Head of Regulatory Affairs in the UK! In this role, you will develop short to long-term business strategies, partner closely with EMEA team members, and achieve relevant patient outcomes, commercial, sales, and growth targets.
This includes developing the vision for and responsible for overall leadership and strategic direction of the Regulatory Affairs team to ensure licenses are obtained in a timely manner in line with business strategy and the business markets products with consistently high quality, safety and efficacy, minimising regulatory enforcement actions.
This includes:- Developing and maintaining a deep understanding of the existing evolving regulatory environment and translating that to impactful regulatory strategies for our product portfolio
- Ensuring regulatory and GMP compliance and inspection readiness at all times
- Ensuring effective interaction and partnership with internal business stakeholders
- Bringing thought leadership on innovative strategic approaches to drive the debate and deliver solutions that shape the regulatory framework
- Ongoing development of regulatory team capabilities, retaining and attracting the best talent
- Lead the UK Regulatory Affairs team, shaping strategy in alignment with UK portfolio, medical, and global priorities.
- Provide strategic oversight for high-quality submissions to the MHRA and ensure alignment with EMEA and local business goals.
- Represent UK Regulatory Affairs in senior forums (e.g., G7 Heads of RA, Medical Leadership Teams), contributing insights and guidance.
- Drive operational efficiency through process improvements, standardisation, and system enhancements.
- Partner with internal teams (medical, marketing, sales, logistics, pricing) to ensure regulatory strategies support broader business objectives.
- Ensure empowered regulatory representation at CVTs and collaborate across EMEA, Global, and ACCESS consortium countries to leverage synergies.
- Develop and lead UK external stakeholder strategy, including strategic engagement with MHRA and other health authorities.
- Influence national policy through ABPI working groups and Office for Life Sciences, in coordination with Health Affairs leadership.
- Monitor and share regulatory trends across UK, Ireland, and EU, contributing to industry advocacy and policy shaping.
- Support GRA-EMEA initiatives and lead change management efforts to embed lessons learned and improve efficiency.
- Collaborate on resource planning and manage the Regulatory Affairs budget effectively.
Education:
- Degree or equivalent experience in Pharmacy, Biology, Chemistry, or related Life Sciences.
- Extensive strategic and operational Regulatory Affairs experience.
- Solid understanding of UK, Ireland, and EU regulatory frameworks.
- Familiarity with GMP, GDP, and QMS standards.
- Proven leadership and team development capabilities.
Required Skills:
Preferred Skills:
