Experienced Regulatory Affairs Professional EMEA

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Job Description:

EMEA Regulatory Affairs Solid Tumours is recruiting for a dedicated Experienced Regulatory Affairs Professional to work on the development and registration of solid tumour products in Europe, the Middle East, and Africa (EMEA).

The Regulatory Affairs Professional supports the development, registration, and lifecycle management of pharmaceutical products within the EMEA region. This role focuses on regulatory tasks such as submission strategies, procedural aspects of regulatory affairs, and compliance with applicable health authority (HA) regulations, project management, and would support the EMEA regulatory leader on regulatory product strategy.

The position can be based in Belgium, The Netherlands, Poland or the United Kingdom. This is a hybrid role with regular weekly presence required in coordination with your team.

This role provides an opportunity to support small and large molecules, and in different oncology indications, contributing to advancements in healthcare.

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.

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 product 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 an 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 clinical trial 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

• Contribute to the development of regulatory submission documents such as briefing documents, Paediatric Investigational Plans (PIPs), and Orphan Drug Designations.
• Review response documents to ensure they thoroughly and accurately address regulatory questions.

Authorization Phase (Marketing Authorization Application - MAA)

• Provide regulatory support to the EMEA Regulatory Leader 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 and acceptance of MAA and subsequent procedural steps.
• Ensure country-specific submission packages are made available to Local Operating Companies (LOCs) in accordance with 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 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, informing regarding product and development status, addressing queries as appropriate

Compliance related activities

• Assist in the 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 , experience and skills

• Bachelor’s degree (BS) in life sciences, medical, or paramedical fields (e.g., pharmacy, biology, veterinary science), or equivalent experience. A Master’s degree (MS), MBA, or higher qualification is considered a plus.
• Experience in pharmaceutical industry or similar and / or Regulatory Affairs
• 2 or more years of regulatory experience, capable of working independently on key tasks while escalating higher-complexity issues
• Experience working in cross-functional teams
• Strong oral & written communication skills in English

Please note that this role is available across multiple countries and may be posted under different requisition numbers to follow 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).

UK - R-085280 

Required Skills:

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The anticipated pay range for this position, in the primary posting location, is:

The anticipated pay ranges for additional locations are:

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.