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 in…
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 in…
Skills: Advanced Analytics, Biostatistics, Collaboration, Compliance Management, Data Privacy Standards
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 in…
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 in…
Skills: Complaint Trending, Signal Detection, Data Analysis, Microsoft Excel, Risk Management
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 in…
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 in…
Skills: Quantitative Mass Spectrometry, LC-HRMS, QqQ Methods, N-nitrosamines Quantitation, Chromatographic Method Development
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 in…
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 in…
Director, Clinical Risk Management Post Approval Delivery Unit
Beerse, Flanders, Belgium · Hybrid
$119k–$204k/yr
Senior+
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 in…
Skills: Budget Management, Clinical Research and Regulations, Clinical Trials Operations, Compliance Management, Compliance Risk
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 in…
Skills: Agile Manufacturing, Business Behavior, Communication, Cost-Benefit Analysis (CBA), Data Analysis
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 in…
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 in…
Skills: Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials
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 in…
Skills: Complaint Management, Complaints Analysis, Complaints Investigation, People Management, Business Alignment
Postdoc Research Scientist, Ion Mobility Mass Spectrometry (IM-MS) and Capillary Electrophoresis MS (CE-MS) (2 years)
Beerse, Flanders, Belgium · On-site
$60k–$96k/yr
Mid level
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 in…
Skills: Ion Mobility Mass Spectrometry, Capillary Electrophoresis MS, Conformational Analysis, Organic Chemistry, Data Analysis
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 in…
Skills: Complaint Management, Complaint Resolution, Complaints Investigation, Business Alignment, Business Behavior
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 in…
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 in…
Skills: AI/ML, Digital Health, Signal Processing, Time-series Modeling, Python
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 in…
Skills: Clinical Operations, Compliance Management, Compliance Risk, Data Reporting, Medicines and Device Development and Regulation
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 in…
Skills: Analytical Reasoning, Clinical Data Management, Collaboration, Data Savvy, Drug Discovery Development
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 in…
Skills: Clinical Supply Chain, SAP S/4HANA, Business Process Ownership, Stakeholder Management, Program Management
The role involves managing the development, registration, and lifecycle of pharmaceutical products for solid tumours across the EMEA region. Key duties include drafting submission strategies, coordinating with health authorities, and ensuring compliance with regional regulations.
Requirements
Candidates must hold a bachelor's degree in life sciences or a related field and possess at least 2 years of regulatory experience in the pharmaceutical industry. Strong English communication skills and the ability to work in cross-functional teams are required.
Full job 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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Beerse, Antwerp, Belgium, Leiden, South Holland, Netherlands, Warsaw, Masovian, Poland
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.
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:
Preferred Skills:
The anticipated pay range for this position, in the primary posting location, is:
zł121,000.00 - zł194,350.00
The anticipated pay ranges for additional locations are:
Netherlands - The anticipated base pay range for this position is 53.500 - 85.445 EUR Belgium - The anticipated base pay range for this position is 63.300 - 97.635 EUR
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.
Related keywords
Regulatory AffairsEMEASolid TumoursOncologyCTAMAAEMAPIPOrphan Drug DesignationPharmaceuticalsLife SciencesHealth AuthorityLifecycle SubmissionsVariationsPost-marketing Commitments
At Johnson & Johnson Innovative Medicine, we innovate with purpose, to lead where medicine is going. The experiences of patients around the world inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science with compassion, we confidently address the most complex diseases of our time and develop the potential medicines of tomorrow. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way. https://bit.ly/3reuMvK
How many Science & Research jobs are open in Beerse, Belgium right now?
There are currently 22 open science & research positions in Beerse, Belgium listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Science & Research roles in Beerse, Belgium?
Companies currently hiring include Johnson & Johnson Innovative Medicine, Johnson & Johnson MedTech, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Science & Research jobs in Beerse, Belgium?
Yes — 15 of the 22 open science & research positions offer remote or hybrid work (0 remote, 15 hybrid).
How do I apply for Science & Research jobs in Beerse, Belgium?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.