At a Glance
- Tasks: Lead the Regulatory Affairs team and develop impactful strategies for product compliance.
- Company: Join a dynamic company focused on patient outcomes and regulatory excellence.
- Benefits: Competitive salary, leadership opportunities, and a chance to shape industry standards.
- Why this job: Make a real difference in healthcare by influencing regulatory frameworks and policies.
- Qualifications: Degree in Life Sciences and extensive experience in Regulatory Affairs required.
- Other info: Collaborative environment with opportunities for professional growth and development.
The predicted salary is between 48000 - 72000 £ per year.
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.
Experience & Skills
- 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.
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Head of Regulatory Affairs employer: Johnson & Johnson
Contact Detail:
Johnson & Johnson Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Regulatory Affairs
✨Tip Number 1
Network like a pro! Reach out to industry contacts on LinkedIn or attend relevant events. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its regulatory strategies. We suggest practising common interview questions with a friend or in front of the mirror. The more comfortable you are, the better you’ll perform!
✨Tip Number 3
Showcase your leadership skills! During interviews, share specific examples of how you’ve led teams or projects in the past. We want to see how you can drive strategic direction and inspire others.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to engage directly with us.
We think you need these skills to ace Head of Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that align with the Head of Regulatory Affairs role. Highlight your strategic oversight and leadership experience, as well as any relevant regulatory achievements.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for our team. Mention specific examples of how you've successfully navigated regulatory challenges in the past.
Showcase Your Collaboration Skills: Since this role involves partnering with various internal teams, be sure to highlight your cross-functional collaboration experience. Share examples of how you've worked with different departments to achieve common goals.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates during the process!
How to prepare for a job interview at Johnson & Johnson
✨Know Your Regulatory Stuff
Make sure you brush up on the latest UK, Ireland, and EU regulatory frameworks. Being able to discuss recent changes or trends in the regulatory environment will show that you're not just knowledgeable but also proactive about staying informed.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led teams in the past. Think about specific challenges you faced and how you motivated your team to achieve regulatory goals. This role is all about leadership, so make sure you highlight your experience in developing and retaining talent.
✨Collaborate Like a Pro
Since this position involves working closely with various internal teams, be ready to discuss how you've effectively collaborated across departments. Share specific instances where your regulatory strategies supported broader business objectives, and how you ensured alignment with other teams.
✨Engage with External Stakeholders
Think about your experience with external stakeholders like health authorities. Be prepared to talk about how you've influenced policy or engaged with organisations like the MHRA. Showing that you can navigate these relationships will set you apart as a candidate who can drive impactful regulatory strategies.