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 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.

Yêu cầu công việc:

Skills & qualifications

• Bachelor's or Master's in Pharma, Medical, or a related scientific discipline
• 8–10 years overall experience, with at least 2 years in project management; regulatory project management experience is a plus.
• Strong knowledge of regional regulatory frameworks, submission processes, and compliance requirements.
• Ability to bridge global regulatory strategies with local execution needs.
• Experience with project management tools (e.g., MS Project or equivalent).
• Strong conceptual and analytical thinking skills.
• Excellent interpersonal and business collaboration skills.
• Intermediate proficiency in MS Office (Word, Excel, Outlook).
• Ability to multitask and prioritize in a fast-paced environment.
• Fluency in local language (written and verbal) plus English proficiency.