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- Tasks: Support regulatory strategy and submissions for innovative healthcare products across EMEA.
- Company: Join Johnson & Johnson, a leader in healthcare innovation.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a real impact on health by working with groundbreaking medical solutions.
- Qualifications: Bachelor's degree in Life Sciences and 2+ years in regulatory affairs.
- Other info: Dynamic team environment with potential relocation to Maidenhead in 2026.
The predicted salary is between 36000 - 60000 £ per year.
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. We develop smarter, less invasive treatments and personal solutions. Through our expertise in Innovative Medicine and MedTech, we innovate across the full spectrum of healthcare solutions to deliver breakthroughs tomorrow and profoundly impact health for humanity.
Janssen EMEA Neuroscience, Cardiovascular, Metabolic and Retina (NCMR) team is recruiting a dedicated Experienced Regulatory Affairs Professional to work on the development and registration of NCMR products in Europe, the Middle East, and Africa (EMEA). The role supports small and large molecules, advanced therapies, and diverse NCMR disease areas. Preferably located in one of our EMEA hubs: Beerse (Belgium), High Wycombe (UK), Leiden (the Netherlands), Madrid (Spain), or Warsaw (Poland). This role is available across multiple countries and may be posted under different requisition numbers; applicants may apply to any or all postings with the expectation that applications will be considered as a single submission.
Responsibilities
- Input in clinical development and post-approval.
- Support the EMEA Regulatory Liaison in developing regulatory strategy and assist in submissions to health authorities from early development, CTAs to MAAs and life‐cycle management.
- Contribute to Global Regulatory Team meetings as the EMEA Regulatory Professional.
- Guide project teams on applicable regulatory requirements, contribute to regional and local regulatory strategy, and help address project‐specific regulatory issues.
- Develop an understanding of the regional regulatory environment, competitor intelligence, and therapeutic areas.
- Liaise with Regulatory Agencies and Local Operating Companies.
- Act as backup for contact with EMA and national Regulatory Agencies.
- Support preparation of meetings with Regulatory Agencies.
- Collaborate with LOCs, track and respond to queries in a timely manner.
- Input in document and process development.
- Assist in the creation and revision of processes related to regulatory submissions.
- Draft and review document content based on regulatory knowledge.
- Contribute to and support the development of briefing documents, paediatric investigational plans, orphan drug designations, and response documents where required.
- Provide input to response documents to ensure they thoroughly and accurately answer questions.
- Track dates of regulatory agency submissions, questions, responses, and approvals.
- Review protocols and ensure alignment with regulatory requirements.
- Provide guidance on CTA submission strategies and documents.
- Ensure CTA submission packages are complete according to agreed timelines.
- Provide regulatory support throughout the life‐cycle of a product.
- Guide and collaborate with cross‐functional teams on required documents and submission strategies in preparation for MAA.
- Identify and supervise critical path activities.
- Assist with timely submission and acceptance of MAA.
- Ensure country‐specific submission packages are made available to the local operating companies in accordance with agreed plans.
Job Requirements – Education and Experience
- Bachelor's degree in Life Sciences, Pharmacy, or a related field; advanced degree preferred, or equivalent by experience.
- Proven experience of 2+ years in regulatory affairs or other relevant functions.
- Experience working in cross‐functional teams.
Skills
- Project management.
- Strong oral & written communication skills.
- Organisation, prioritisation, and multi‐tasking skills.
Knowledge
- Knowledge of the pharmaceutical regulatory environment, guidelines, and practice in EMEA, particularly the EU.
The office will relocate to central Maidenhead from October 2026; applicants should ensure this location is suitable for them.
Experienced Regulatory Affairs Professional EMEA in High Wycombe employer: Johnson & Johnson Innovative Medicine
Contact Detail:
Johnson & Johnson Innovative Medicine Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Experienced Regulatory Affairs Professional EMEA in High Wycombe
✨Tip Number 1
Network like a pro! Reach out to folks in the industry on LinkedIn or at events. A friendly chat can open doors that applications alone can't.
✨Tip Number 2
Prepare for interviews by researching Johnson and Johnson's latest innovations. Show us you’re passionate about healthcare and ready to contribute to our mission!
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the role. We want to hear how you can make an impact in regulatory affairs.
✨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. Let’s get you on board!
We think you need these skills to ace Experienced Regulatory Affairs Professional EMEA in High Wycombe
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Experienced Regulatory Affairs Professional. Highlight your relevant experience in regulatory affairs, especially in EMEA, and showcase any specific projects you've worked on that align with the job description.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your background makes you a perfect fit for Johnson and Johnson. Don’t forget to mention your understanding of the pharmaceutical regulatory environment in EMEA.
Showcase Your Communication Skills: Since strong communication skills are key for this role, make sure your application reflects that. Use clear, concise language and structure your documents well. This will demonstrate your ability to communicate effectively, which is crucial in regulatory affairs.
Apply Through Our Website: We encourage you to apply through our website for the best chance of success. It’s straightforward and ensures your application goes directly to the right team. Plus, you’ll find all the details you need about the role and our company!
How to prepare for a job interview at Johnson & Johnson Innovative Medicine
✨Know Your Regulatory Stuff
Make sure you brush up on the latest EMEA regulatory guidelines and practices. Familiarise yourself with the specific requirements for clinical trial applications and marketing authorisation applications, as these will likely come up in your interview.
✨Showcase Your Experience
Prepare to discuss your previous roles in regulatory affairs, especially any experience with cross-functional teams. Be ready to share specific examples of how you've contributed to regulatory strategies or submissions in the past.
✨Understand the Company’s Mission
Johnson and Johnson is all about health innovation. Research their recent projects and initiatives in the NCMR space. This will help you align your answers with their goals and demonstrate your genuine interest in the role.
✨Ask Insightful Questions
Prepare a few thoughtful questions to ask at the end of your interview. Inquire about the team dynamics, upcoming projects, or how they measure success in regulatory affairs. This shows you're engaged and serious about the position.
