Senior Principal Scientist, CMC Dossier Development (Pharmaceutical Regulatory Science)

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

Salary: €96,000–€165,025 annually in the primary posting location; an additional location range is €82,900–€144,210.

Company

Johnson & Johnson MedTech develops healthcare solutions across innovative medicine and medical technology.

What you will do

• Develop and coordinate technical eCTD sections for CMC regulatory dossiers supporting clinical trial and marketing applications.
• Lead dossier authoring for early- and late-stage regulatory filings, including NDA/BLA programs.
• Coordinate timelines, virtual document generation, and Quality module preparation.
• Support responses to health authority inquiries while ensuring complete, accurate, and compliant submission data.
• Represent the function on multidisciplinary development teams and collaborate with CMC, Regulatory, Supply Chain, Clinical Operations, Therapeutic Areas, and external providers.
• Lead functional or cross-functional teams of up to 15 members and drive process improvements.

Requirements

• PhD with 6+ years of relevant postdoctoral experience, or a bachelor's/master's degree in chemical, biological, pharmaceutical, or related sciences with 8+ years of relevant experience.
• Proven experience leading dossier authoring for synthetic and/or biologic products.
• Experience with CMC regulatory submissions, eCTD format, and regulatory guidelines including FDA and EMA requirements.
• Experience preparing CMC documents for marketing applications and clinical trial submissions.
• Experience collaborating with multidisciplinary internal teams and external partners.
• Strong leadership, communication, analytical, problem-solving, prioritization, and independent working skills.

Nice to have

• Experience developing and implementing strategic dossier development and product timeline plans.
• Experience across both synthetic and biologic product modalities.

Culture & Benefits

• Inclusive work environment focused on diversity, dignity, and individual recognition.
• Annual performance-based bonus or sales commissions, depending on role 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 and service anniversary and recognition awards, subject to applicable plan terms.