Senior Global CMC Regulatory Scientist

Johnson & Johnson Innovative Medicine; Leiden; Hybrid; EUR 69,000 - 120,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Job summary

Johnson & Johnson Innovative Medicine in Leiden, Netherlands, is seeking a Principal Scientist (Manager) for Global Regulatory Affairs, CMC. The role is onsite/hybrid and focuses on global CMC regulatory strategies for large molecules in development and post‑marketing. You will lead dossier preparation and regulatory planning across markets.

The candidate will guide teams on EU/FDA rules, support health authority interactions, and drive continuous regulatory compliance and lifecycle management.

Qualifications

• BS/BA in biological, pharmaceutical, chemical or engineering sciences with 8+ years of experience; MS/PhD preferred.
• Strong knowledge of EU and FDA regulations.
• Experience with regulatory strategies for biologics and large molecules.

Responsibilities

• Lead regulatory CMC activities within global teams to support product development.
• Develop global CMC regulatory strategies and dossier content plans.
• Prepare regulatory dossiers for Health Authorities submissions.
• Provide guidance on interpretation of global CMC regulations.
• Collaborate with cross-functional teams to align regulatory plans with lifecycle management.
• Communicate with health authorities and manage key interactions.

Skills

Regulatory strategy

CMC expertise

Global collaboration

Regulatory writing

Project leadership

Education

BS/BA in biological, pharmaceutical, chemical or engineering sciences

MS/PhD preferred

Job description

Johnson & Johnson Innovative Medicine in Leiden, Netherlands, is seeking a Principal Scientist (Manager) for Global Regulatory Affairs, CMC. The role is onsite/hybrid and focuses on global CMC regulatory strategies for large molecules in development and post‑marketing. You will lead dossier preparation and regulatory planning across markets.

The candidate will guide teams on EU/FDA rules, support health authority interactions, and drive continuous regulatory compliance and lifecycle management.