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- Tasks: Lead the Regulatory Affairs team and shape strategies for impactful healthcare solutions.
- Company: Join Johnson & Johnson, a leader in healthcare innovation and inclusivity.
- Benefits: Competitive salary, inclusive environment, and opportunities for professional growth.
- Other info: Collaborative culture with a focus on employee development and diversity.
- Why this job: Make a real difference in healthcare by shaping regulatory strategies and policies.
- Qualifications: Degree in Life Sciences and extensive experience in Regulatory Affairs required.
The predicted salary is between 80000 - 100000 £ 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.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
**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**
- 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**
- 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.
Head of Regulatory Affairs 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
✨Tip Number 1
Network like a pro! Reach out to current or former employees at Johnson & Johnson on LinkedIn. A friendly chat can give you insider info and maybe even a referral, which can really boost your chances.
✨Tip Number 2
Prepare for the interview by researching the latest trends in regulatory affairs. Show that you’re not just knowledgeable but also passionate about how these trends impact patient outcomes and business strategies.
✨Tip Number 3
Practice your answers to common interview questions, especially those related to leadership and strategic thinking. We want to see how you can lead the Regulatory Affairs team effectively!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining our team.
We think you need these skills to ace Head of Regulatory Affairs
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Head of Regulatory Affairs role. Highlight your relevant experience in regulatory frameworks and leadership, showing how you align with Johnson & Johnson's mission to innovate in healthcare.
Showcase Your Expertise: Don’t hold back on demonstrating your knowledge of UK, Ireland, and EU regulatory environments. Use specific examples from your past roles to illustrate how you've successfully navigated these frameworks and contributed to business goals.
Be Personable: While professionalism is key, don’t forget to let your personality shine through! Johnson & Johnson values an inclusive environment, so showing your collaborative spirit and ability to engage with diverse teams can set you apart.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets the attention it deserves and allows us to see your enthusiasm for joining the Johnson & Johnson team!
How to prepare for a job interview at J&J Family of Companies
✨Know Your Regulatory Stuff
Make sure you brush up on the latest UK, Ireland, and EU regulatory frameworks. Johnson & Johnson is looking for someone who can navigate these waters with ease, so be prepared to discuss how your experience aligns with their needs.
✨Showcase Your Leadership Skills
As a Head of Regulatory Affairs, you'll need to demonstrate your leadership capabilities. Think of examples where you've successfully led a team or project, especially in a regulatory context, and be ready to share those stories during the interview.
✨Understand Their Business Strategy
Familiarise yourself with Johnson & Johnson's business goals and how the Regulatory Affairs team fits into that picture. Be ready to discuss how you can contribute to achieving patient outcomes and commercial targets through effective regulatory strategies.
✨Engage with Cross-Functional Collaboration
Highlight your experience working with various internal teams like medical, marketing, and sales. Johnson & Johnson values collaboration, so prepare to discuss how you've successfully partnered with different departments to drive regulatory success.