Head of Regulatory Affairs
Head of Regulatory Affairs
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at
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 Opportunity
An 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
Key Responsibilities
Regulatory Strategy & Leadership
- 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.
Cross-Functional Collaboration
- 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.
External Engagement
- 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.
Operational Excellence
- 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.
Qualifications
Education:
- Degree or equivalent experience in Pharmacy Biology Chemistry or related Life Sciences.
Experience & Skills:
- 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.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law.
We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.
Required Experience:
Director
Employment Type
Full-Time
