Manager Global Regulatory Scientist, Regulatory Affairs

Location: Hybrid role based in Beerse, Belgium; Leiden, Netherlands; High Wycombe or Maidenhead, United Kingdom; Raritan, New Jersey, or Spring House, Pennsylvania, United States

Salary: $117,000–$201,250 per year

Company

Johnson & Johnson MedTech develops healthcare solutions and innovative medicines to prevent, treat, and cure complex diseases.

What you will do

• Draft cover letters and support IND, CTA, MAA, NDA, 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, acceptance processes, and responses to health authority queries.
• Prepare for regulatory agency meetings and contribute to responses, inspections, audits, litigation support, and product complaint activities.
• Drive project planning for global submissions, health authority interactions, and major regulatory milestones.
• Research regulatory and medical information, assess competitive precedents, and contribute to regulatory strategy and process improvements.

Requirements

• Bachelor’s degree in a scientific discipline with at least 6 years of regulated healthcare 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 IND, CTA, NDA, BLA, and MAA submissions.
• Experience in strategic planning, technical data summaries, and cross-functional management.
• Strong organization, communication, collaboration, critical thinking, leadership, and contingency-planning skills; approximately 10% domestic travel and potential international travel may be required.

Nice to have

• Advanced scientific degree.
• Knowledge of multiple global health authority regulations and processes.
• Oncology experience.
• Experience with combination products involving drugs and devices.

Culture & Benefits

• Inclusive, respectful environment guided by the company’s Credo.
• Participation in pension, savings, and 401(k) plans, subject to plan terms.
• Eligibility for the long-term incentive program.
• Vacation, sick time, holidays, parental leave, caregiver leave, bereavement leave, volunteer leave, and other paid time-off benefits.