Project Manager (Regulatory)

Mô tả công việc:

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 coordination and compliance oversight.
• Leads scenario planning and risk mitigation activities.
• Tracks content plans with functional teams to ensure timely delivery.
• Manages rapid response processes for health authority queries.
• Supports advisory committee and health authority meeting preparations.
• Coordinates authoring, review, and approval of regulatory documents.
• Leads lessons-learned activities and maintains associated logs.
• Acts as subject matter expert for local and regional regulatory requirements.
• Supports localization of regulatory strategies and submissions per regional authority requirements.
• Ensures compliance with country-specific regulations, formats, and timelines.
• Provides translation support or review of submission documents in the local language, as needed.