Senior Regulatory Affairs Professional- GRA EMEA HAEMATOLOGY

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Job Description

EMEA Regulatory Affairs Hematology is recruiting for a dedicated Regulatory Affairs Professional to work on the development and registration of hematology products in Europe, the Middle East, and Africa (EMEA). The position can be based in Poland, Spain, Belgium, The Netherlands or the United Kingdom. This is a hybrid work position

This role provides an opportunity to support small and large molecules, as well as advanced therapies, and in different oncology indications, contributing to advancements in 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.

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

• Contribute to portfolio optimization activities such as delisting’s and divestments, as appropriate.

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

• 3–4 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 - Requisition Number: R-054607

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

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