At a Glance
- Tasks: Lead the Regulatory Affairs team and shape strategies for impactful healthcare solutions.
- Company: Join Johnson & Johnson, a leader in healthcare innovation and patient-focused solutions.
- Benefits: Inclusive workplace, competitive salary, and opportunities for professional growth.
- Why this job: Make a real difference in healthcare by shaping regulatory strategies that impact lives.
- Qualifications: Degree in Life Sciences and extensive experience in Regulatory Affairs required.
- Other info: Collaborative environment with a commitment to employee development and diversity.
The predicted salary is between 43200 - 72000 £ per year.
At Johnson & 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.
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.
Head of Regulatory Affairs in High Wycombe employer: J&J Family of Companies
Contact Detail:
J&J Family of Companies Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Regulatory Affairs in High Wycombe
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend events, and connect with people on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your own. This will help you answer questions more authentically and show that you're genuinely interested in being part of their team.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or use online resources to refine your answers. Focus on articulating your experience and how it relates to the role of Head of Regulatory Affairs.
✨Tip Number 4
Don’t forget to follow up after interviews! A simple thank-you email can go a long way in leaving a positive impression. Plus, it shows your enthusiasm for the position and keeps you on their radar.
We think you need these skills to ace Head of Regulatory Affairs in High Wycombe
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your relevant experience in Regulatory Affairs. We want to see how your skills align with the specific responsibilities mentioned in the job description.
Showcase Your Leadership Skills: As a Head of Regulatory Affairs, leadership is key! Use your application to demonstrate your past experiences in leading teams and driving strategic initiatives. We love seeing examples of how you've developed talent and shaped team capabilities.
Highlight Your Regulatory Knowledge: We’re looking for someone with a solid understanding of UK, Ireland, and EU regulatory frameworks. Make sure to include any relevant certifications or experiences that showcase your expertise in this area.
Apply Through Our Website: Don’t forget to submit your application through our official website! It’s the best way for us to receive your details and ensure you’re considered for this exciting opportunity.
How to prepare for a job interview at J&J Family of Companies
✨Know Your Regulatory Landscape
Before the interview, dive deep into the current UK, Ireland, and EU regulatory frameworks. Understanding the nuances of these regulations will not only impress your interviewers but also show that you're proactive and well-prepared for the role.
✨Showcase Your Leadership Skills
As a Head of Regulatory Affairs, leadership is key. Prepare examples of how you've successfully led teams in the past, particularly in high-pressure situations. Highlight your ability to develop talent and foster collaboration across departments.
✨Prepare for Cross-Functional Questions
Expect questions about how you would collaborate with internal teams like medical, marketing, and sales. Think of specific instances where your regulatory strategies supported broader business objectives and be ready to discuss them.
✨Engage with External Stakeholders
Be prepared to talk about your experience with external engagement, especially with health authorities like the MHRA. Discuss any strategies you've implemented to influence policy or engage with industry groups, as this will demonstrate your ability to navigate the regulatory landscape effectively.