Regulatory Project Manager

About the role

Roche is seeking a Regulatory Project Manager to join its Regulatory Affairs division. The role focuses on managing stakeholders, navigating complex compliance pathways, and driving product approvals while ensuring strict regulatory compliance.

Key responsibilities

• Oversee development of medium‑to‑high complexity submission and product registration dossiers and secure marketing approvals from health authorities.
• Lead cross‑functional teams, foster collaboration, and resolve conflicts to achieve project goals.
• Communicate and partner with internal and external teams to understand requirements and deliver optimal regulatory solutions.
• Apply agile principles to regulatory activities, encouraging open exchange of ideas among stakeholders.
• Execute scheduled and unscheduled activities with minimal guidance, using VACC principles to influence colleagues without direct authority.
• Troubleshoot operational issues, develop cost‑effective solutions, and simplify processes to increase productivity.

Required profile

• Bachelor's or Master's degree in Life Science, Data Science, or a related field, or equivalent laboratory technician qualification.
• 5–10 years of experience in Regulatory, R&D, Quality, Operations, or Clinical environments.
• Proven track record handling healthcare regulatory affairs and managing high‑complexity or global projects.
• Ability to work independently, generate new ideas, and take initiative.

Required skills

• Deep understanding of global healthcare regulatory frameworks.
• Experience with agile methodologies in regulatory contexts.
• Strong stakeholder management and communication abilities.