Manager Global Regulatory Scientist, Regulatory Affairs (Pharmaceuticals)

Location: Hybrid position based in Beerse, Belgium; Leiden, Netherlands; High Wycombe or Maidenhead, UK; or Raritan or Spring House, USA

Base pay: €79,800–€137,770 annually

Company

Johnson & Johnson MedTech operates within Johnson & Johnson's healthcare organization, developing innovative medicines, medical technologies, and healthcare solutions.

What you will do

• Prepare cover letters and support IND, CTA, NDA, MAA, BLA, eCTD, and other global regulatory submissions.
• Advise teams on regulatory requirements, required documentation, submission strategies, and country-specific packages.
• Coordinate submission timelines, critical-path activities, health authority interactions, meetings, and responses to regulatory queries.
• Liaise with local operating companies, regulatory colleagues, and health authorities throughout registration and lifecycle management.
• Provide regulatory input for inspections, audits, litigation support, product complaints, and major regulatory milestones.
• Research regulatory and medical information, contribute to strategy development, and improve regulatory processes.

Requirements

• Bachelor’s degree in a scientific discipline with at least 6 years of regulated-health-industry experience, or a Master’s degree with at least 5 years, or a PhD/PharmD with at least 4 years.
• At least 4 years of relevant regulatory affairs experience in the pharmaceutical or biotech industry.
• Strong knowledge of FDA and ICH requirements for clinical research, product development, lifecycle submission management, and product labeling.
• Experience preparing health authority responses, managing regulatory interactions, and supporting clinical trial and marketing authorization submissions.
• Experience in strategic planning, technical data summaries, cross-functional management, collaboration, and work in a matrixed environment.
• Up to 10% domestic travel and potential international travel may be required.

Nice to have

• Advanced scientific degree.
• Experience across pharmaceuticals, medical devices, and combination products.
• Oncology therapeutic-area experience.
• Knowledge of regulations and processes across multiple global health authorities.

Culture & Benefits

• Inclusive work environment focused on healthcare innovation and patient impact.
• Annual bonus with a target determined by pay grade and location.
• Vacation, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
• Well-being reimbursement and financial, physical, and mental health programs.
• Insurance plans, service anniversary awards, and recognition awards, subject to local plan terms.