Regulatory Affairs Manager / Senior Manager – CMC

About the role

Novartis is looking for a Manager or Senior Manager to lead regulatory activities for Chemistry, Manufacturing and Controls (CMC). The role will drive global CMC regulatory strategy, prepare and publish CMC documentation for health‑authority submissions, and support new product launches and post‑marketing activities from the Basel site.

Key responsibilities

• Define and implement global CMC regulatory strategy aligned with business and compliance goals.
• Plan, author, review, coordinate and submit CMC dossiers for assigned products.
• Identify documentation requirements, resolve content or timeline issues, and ensure delivery of approved technical source documents.
• Author and review high‑quality CMC sections for health‑authority submissions, adhering to current guidelines and e‑publishing standards.
• Communicate CMC regulatory risks, strategies and issues to project teams and cross‑functional stakeholders.
• Lead CMC risk assessments, lessons‑learned documentation and health‑authority interactions.

Required profile

• Science degree (e.g., Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) or equivalent.
• Minimum 5 years of regulatory CMC experience in the pharmaceutical industry.
• Demonstrated knowledge of regulatory submission and approval processes and ability to manage complex CMC issues.
• Strong analytical ability to evaluate data across scientific disciplines.

Required skills

• Regulatory affairs expertise in CMC.
• Preparation and review of CMC documentation for health‑authority submissions.
• Health‑authority interaction and negotiation.

What we offer

• Opportunity to influence global CMC strategy within a leading innovative pharma company.
• Inclusive work environment committed to diversity and equal opportunity.