Experienced Regulatory Affairs Professional EMEA

Janssen EMEA Neuroscience, Cardiovascular, Metabolic and Retina (NCMR) team is recruiting for 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 job provides an opportunity to support small and large molecules, as well as advanced therapies, and in different NCMR disease areas, contributing to healthcare one patient at a time.

The successful applicant will help develop and implement regulatory strategies to achieve efficient development and timely commercialization of innovative pharmaceutical products in compliance with applicable regulations.

1. Input in clinical development and post-approval

• Support the EMEA Regulatory Liaison in developing the regulatory strategy for products in development 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

2. Liaison with Regulatory Agencies and Local Operating Companies

• Act as backup for contact with EMA and national Regulatory Agencies
• Support the preparation of meetings with Regulatory Agencies
• Collaborate with LOCs, track and respond to queries in a timely manner

3. 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 the questions being posed
• Track dates of regulatory agency submissions, questions, responses, and approvals

4. Clinical Trial Applications

• Review protocols and ensure alignment with regulatory requirements
• Provide guidance to team on CTA submission strategies and documents
• Ensure CTA submission packages are complete according to agreed timelines

5. 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 (LOCs) in accordance with agreed plans

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
• Organization, prioritising, and multi-tasking skills

Knowledge

Knowledge of the pharmaceutical regulatory environment, guidelines, and practice in EMEA, particularly the EU.

Hybrid Work