Regulatory Program Manager – CMC (Pharma)

About the role

Roche is seeking a Regulatory Program Manager to join its Regulatory Centralization Team. You will be responsible for preparing and submitting high‑quality CMC regulatory documents worldwide, ensuring compliance with cGMP, Roche standards, and health‑authority requirements throughout the product lifecycle.

Key responsibilities

• Prepare, review and submit CMC regulatory dossiers to global health authorities.
• Maintain data accuracy and compliance in Regulatory Information Management (RIM) systems.
• Coordinate cross‑functional PTR deliverables to support timely product approvals.
• Contribute to regulatory excellence, risk mitigation and continuous process improvement.
• Interpret and apply international regulations, ICH guidelines and health‑authority expectations (US, EU, Canada, etc.).

Required profile

• Bachelor’s degree in Life Sciences, Pharmacy, Quality or related field (Master’s a plus).
• Proven experience in regulatory affairs, quality assurance or compliance within the pharmaceutical/biopharma industry.
• Strong knowledge of global health‑authority regulations, GxP/cGMP, and ICH framework.
• Advanced written and spoken English for daily global collaboration.

Required skills

• Regulatory affairs expertise.
• Quality assurance and compliance knowledge.
• GxP/cGMP guidelines.
• ICH guidelines implementation.
• Regulatory Information Management (RIM) systems.