At a Glance
- Tasks: Guide teams on regulatory requirements and support product registration across EMEA.
- Company: Join a leading pharmaceutical company committed to innovation and diversity.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on career development and diversity.
- Why this job: Make a real impact in healthcare by supporting life-saving products.
- Qualifications: Bachelor's degree in life sciences and 2+ years in regulatory affairs.
The predicted salary is between 50000 - 65000 £ per year.
About the Role
EMEA Regulatory Affairs Solid Tumours is recruiting a dedicated Experienced Regulatory Affairs Professional to support development and registration of solid tumour products across the EMEA region.
General Regulatory Responsibilities
- Guide project teams on regulatory requirements and contribute to regional and local regulatory strategies.
- Support the EMEA Regulatory Leader in developing regulatory strategies for products in development.
- Assist in submissions to health authorities, including CTAs, MAAs, and lifecycle submissions.
- Contribute to global regulatory and cross‑functional meetings as the EMEA Regulatory Professional.
- Develop understanding of the regional regulatory environment, therapeutic area, and competitor intelligence.
- Draft and review document content based on regulatory knowledge.
Pre‑Authorization Activities – Clinical Trial Applications (CTA)
- Review protocols to ensure alignment with regulatory requirements.
- Provide guidance on CTA submission strategies and documents such as protocols and Investigator’s Brochures (IB).
- Coordinate responses to Health Authority Questions (HAQs).
Scientific Advice, Orphan Drug Designation, and Paediatrics
- Develop regulatory submission documents such as briefing documents, Paediatric Investigational Plans (PIPs), and Orphan Drug Designations.
- Review response documents to ensure they address regulatory questions fully and accurately.
Authorization Phase – Marketing Authorization Application (MAA)
- Provide regulatory support throughout the product lifecycle.
- Guide and collaborate with cross‑functional teams on required documents and submission strategies for MAA preparation.
- Identify and supervise critical path activities; assist with timely submission, acceptance of MAA, and subsequent procedural steps.
- Ensure country‑specific submission packages are available to Local Operating Companies (LOCs) per agreed plans.
Lifecycle Activities
- Support lifecycle submissions and post‑approval regulatory activities including variations, post‑marketing commitments, and safety‑related submissions.
- Maintain oversight of regional lifecycle submissions.
Liaison with Regulatory Agencies and LOCs
- Act as backup contact for EMA and national regulatory agencies.
- Support preparation of meetings with regulatory agencies.
- Collaborate with LOCs, informing them regarding product and development status and addressing queries.
Compliance Related Activities
- Assist in creation and revision of processes related to regulatory submissions.
- Appropriately manage Regulatory Affairs related systems and processes according to regulatory and company standards.
Job Requirements
- Education: Bachelor’s degree in life sciences, medical, paramedical fields (e.g., pharmacy, biology, veterinary science) or equivalent experience.
- Preferred: Master’s degree, MBA, or higher qualification.
- Experience: ≥2 years in pharmaceutical industry or similar and/or regulatory affairs; ability to work independently on key tasks while escalating higher‑complexity issues.
- Experience working in cross‑functional teams.
- Strong oral and written communication skills in English.
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.
Experienced Regulatory Affairs Professional EMEA in High Wycombe employer: 7360-Janssen-Cilag Limited Legal Entity
At Johnson & Johnson, we pride ourselves on being an exceptional employer, offering a collaborative and inclusive work culture that values diversity and individual contributions. Located in High Wycombe, Buckinghamshire, our team enjoys access to robust employee growth opportunities, comprehensive benefits, and the chance to make a meaningful impact in the field of regulatory affairs for solid tumour products across the EMEA region.
Contact Details:
7360-Janssen-Cilag Limited Legal Entity Recruitment Team
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