Experienced Regulatory Affairs Professional EMEA
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Job Location:
High Wycombe - UK
Monthly Salary:
Not Disclosed
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at
Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
High Wycombe Buckinghamshire United KingdomJob 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 Description
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.
This role is preferred to be located in one of our J&J EMEA hubs (Beerse Belgium; High Wycombe UK; Leiden the Netherlands; Madrid Spain or Warsaw Poland)
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).
Beerse Leiden Madrid Warsaw - Requisition Number: R-053480
Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.
Please note that our office will be relocating to central Maidenhead from October 2026. Applicants should ensure that this location is suitable for them.
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
Job Requirements
Education and experience
Bachelors 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.
Required Skills:
Preferred Skills:
Required Experience:
Senior IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
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