Experienced Regulatory Affairs Professional EMEA

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 Med Tech, we innovate across the full spectrum of healthcare solutions to deliver breakthroughs tomorrow and profoundly impact health for humanity.

Learn more at

Regulatory Affairs Group

Regulatory Affairs

Professional

High Wycombe, Buckinghamshire, United Kingdom

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.

• 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.
• Clinical Trial Applications.
• 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.
• Marketing Authorization Applications.
• 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.

• Bachelor’s degree in Life Sciences, Pharmacy, or a related field; advanced degree.

• Proven experience of 2+ years in regulatory affairs or other relevant functions.
• Experience working in cross‑functional teams.

• Project management.
• Strong oral & written communication skills.
• Organisation, prioritisation, and multi‑tasking skills.

• 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.