Project Manager (Regulatory)

About the role

We are looking for an experienced Regulatory Project Manager to independently manage global submissions, lead cross-functional teams, and support regional regulatory strategies. This role bridges global regulatory direction with local market execution and compliance.

Key responsibilities

• Independently manages submissions and supports major global regulatory filings.
• Leads cross-functional team meetings alongside regulatory leads.
• Develops, maintains, and tracks submission timelines; identifies critical paths and risks.
• Plans and facilitates kick-off and ongoing project meetings including agenda, coordination, and presentations.
• Documents meeting minutes, decisions, risks, and action items.
• Maintains project plans, dashboards, and collaborative workspaces.
• Supports regulatory activities related to contract manufacturing and product transitions, including partner coordinatio...