Exp professional Regulatory Affairs

manity. Learn more at https://https://www.jnj.com

Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Beerse, Antwerp, Belgium, Issy-les-Moulineaux, Hauts-de-Seine, France, Leiden, South Holland, Netherlands, Madrid, Spain, Warsaw, Masovian, Poland
Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://https://www.jnj.com/innovative-medicine

Job Description

Janssen EMEA Oncology is recruiting for a dedicated Experienced or Senior Regulatory Affairs Professional, Affairs to work on the development and registration of Haematology or Solid Tumor Oncology products in Europe, the Middle East, and Africa (EMEA)! The position can be based in Belgium, The Netherlands or the United Kingdom - other locations can be discussed on a case-by-case basis. The job provides an opportunity to support small and large molecules, as well as advanced therapies, and in different oncology indications, 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 CTAs to MAAs and variations.

• Contribute to Global Regulatory 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 area

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

Job Requirements

Education and experience

• Master's degree - medical or paramedical (pharmacy, biology, veterinary, etc.), or equivalent by experience

• Proven experience of 2+ years in regulatory affairs or other relevant functions (4+ for Senior).

• Experience working in cross-functional teams

Skills

• Project management

• Strong oral & written communication skills

• Organization, prioritising, and multi-tasking skills

Knowledge

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

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.

While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United Kingdom - Requisition Number: R-005901

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.