Experienced Regulatory Affairs Professional EMEA

Job Function: Regulatory Affairs Group
Job Sub Function: Regulatory Affairs
Job Category: Professional

All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom

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.