Principal Scientist, CMC Dossier Development

Location: Beerse, Antwerp, Belgium, or Leiden, South Holland, Netherlands

Salary: €79,800–€137,770 annual base pay in Belgium; Netherlands range: €68,600–€119,600 annual base pay

Company

Johnson & Johnson MedTech develops healthcare solutions focused on preventing, treating, and curing complex diseases through innovative medicine and medical technology.

What you will do

• Develop and author technical eCTD sections for CMC regulatory dossiers supporting clinical trial and marketing applications.
• Coordinate dossier timelines, virtual document generation, and Quality module preparation.
• Support dossier strategy and product development plans for early- and late-stage regulatory filings.
• Prepare responses to health authority inquiries and ensure the completeness, accuracy, and compliance of submission data.
• Represent the function on multidisciplinary development teams and coordinate internal departments and external service providers.
• Lead functional or cross-functional teams of up to 10 members, supervise consultants, and drive process improvements.

Requirements

• PhD with 3+ years of relevant postdoctoral experience, or a bachelor's or master's degree in chemical, biological, pharmaceutical sciences, or a related field with 6+ years of relevant experience.
• Required experience authoring dossiers for synthetic and/or biologic products.
• Required excellent written and oral communication skills for explaining complex technical information to diverse partners.
• Required strong analytical and problem-solving abilities, independence, adaptability, and the ability to manage multiple priorities.
• Familiarity with CMC regulatory submissions, eCTD format, and FDA or EMA guidelines is preferred.
• Experience with complex pharmaceutical or biotech regulatory projects, strategic planning, team leadership, mentoring, and resource coordination is preferred.

Culture & Benefits

• Inclusive work environment focused on individual dignity, diversity, and merit.
• Annual bonus based on pay grade, location, and employee and company performance.
• 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.
• Recognition awards and access to insurance plans subject to applicable plan terms and location.