Head of Regulatory Affairs

Overview

At Johnson and Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.comJob Function:

Regulatory Affairs GroupJob Sub Function:

Regulatory AffairsJob Category:

People LeaderAll Job Posting Locations:

High Wycombe, Buckinghamshire, United KingdomThe 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 portfolioEnsuring regulatory and GMP compliance and inspection readiness at all timesEnsuring effective interaction and partnership with internal business stakeholdersBringing thought leadership on innovative strategic approaches to drive the debate and deliver solutions that shape the regulatory frameworkOngoing development of regulatory team capabilities, retaining and attracting the best talentKey Responsibilities

Regulatory Strategy and LeadershipLead 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 CollaborationPartner 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 EngagementDevelop 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 ExcellenceSupport 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 and 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 and 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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation ..... full job details .....