EMEA Regulatory Leader

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

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium, Leiden, Netherlands, Warsaw, Masovian, Poland

Job Description:

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

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).

High Wycombe, UK- Requisition Number: R-040087

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

Job Description

GRA Europe, the Middle East, and Africa (EMEA) at Johnson & Johnson Innovative Medicine is recruiting for a dedicated Regulatory Affairs Leader to contribute to the development and registration of products in Neuroscience. The job provides an opportunity to work on small and large molecules including advanced therapy medicinal products (ATMPs) in different indications, contributing to healthcare one patient at a time

This role is preferred to be located in one of our J&J EMEA hubs (Beerse, Belgium High Wycombe, UK, Leiden, the Netherlands, or Warsaw, Poland) but other EMEA company locations can be considered.

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

Key Responsibilities:Develop regulatory strategies for innovative new medicines

• Develop and drive implementation of regional regulatory strategies in support of the global development plan

• Apply relevant competitor intelligence and therapeutic area knowledge

• Drive the target EU SmPC based on an understanding of the regional regulatory strategy, and cross-functional needs.

Liaison with Regulatory Agencies and Local Operating Companies (LOCs)

• Establish strong working relationships with regulators to lead effective interactions on clinical study design, submissions content, product-specific labeling, and post-approval commitments

• Act as primary contact with the European Medicines Agency (EMA), working through LOC for National Regulatory Agencies contacts, as appropriate

• Ensure that issues raised by Regulatory Agencies are promptly and adequately addressed and ensure implementation of Regulatory Agency comments into the clinical development plan

Input in document and process development

• Draft and review document content based on regulatory and scientific knowledge

• Contribute to and support the preparation of briefing documents, paediatric investigational plans, orphan drug designations, summary document and response documents. Ensure these supports the regional strategy and target label.

• Assist in the development of processes related to regulatory submissions

Clinical Trial Applications (CTA)

• Ensure protocols support registration, reimbursement, and differentiated labeling

• Guide cross-functional team on EMEA CTA requirements

• Ensure CTA submissions complete and available according to agreed timelines

Marketing Authorization Application

• Provide regulatory leadership throughout registration process and post-approval

• Manage submissions, define submission plans, and provide inputs to team on required documents and submission strategies in preparation of MAAs.

• Ensure timely MAA availability, track critical path activities

• Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans

QualificationsEducation and experience

• Bachelor's degree in Life Sciences, Pharmacy, or a related field; advanced degree

preferred.

• Regulatory experience in drug development and commercialization

• Extensive experience with EU regulatory procedures

• Experience in working in project teams and cross-functional teams

Skills

• Negotiation and conflict resolution skills

• Oral & written communication skills

• Organization, prioritizing, project management & multi-tasking skills

Knowledge

• Excellent knowledge of English

• Knowledge of the applicable therapeutic area preferred

• In-depth knowledge of regulatory environment, guidelines, and practice of EMEA regions

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