Senior Regulatory Program Manager, Global Integration

Moderna Therapeutics; Cambridge (MA); Hybride; USD 131 000 - 209 000; Plein temps

Avantages offerts par ce poste

Healthcare benefits

Voluntary benefits

Well-being programs

Family planning benefits

Paid time off

Savings & investments

Location-specific perks

Résumé du poste

Moderna Therapeutics is seeking a Senior Manager, GRS Integration to support multiple development and commercial programs within Global Regulatory Science. You will translate regulatory strategy into coordinated plans, manage milestones, and partner across GRLs, Country Regulatory Leads, and CMC teams to ensure timely submissions and regulatory commitments.

You will lead planning discussions, manage trackers and dashboards, and proactively identify risks while driving cross-program enhancements

Qualifications

• BA/BS in a scientific, engineering, healthcare, business, or related discipline.
• Minimum of 5 years of progressive experience in pharma/biotech or life sciences.
• Experience in regulatory planning, submissions, and lifecycle management.
• Ability to coordinate across multiple stakeholders in a matrix organization.
• Strong project management, organizational, and facilitation skills.

Responsabilités

• Develop, maintain, and execute integrated regulatory plans with GRLs and cross-functional partners.
• Translate regulatory strategy into actionable plans, milestones, and timelines.
• Manage regulatory plans, trackers, dashboards, and planning tools for visibility.
• Facilitate regulatory team meetings and ensure decisions and actions are tracked.
• Identify risks and dependencies; develop mitigation plans and scenario planning.
• Support regulatory activities including submissions and health authority interactions.
• Contribute to continuous improvement of GRS Integration processes.

Connaissances

Project management

Regulatory planning

Cross-functional collaboration

Risk management

Communication & influencing

Prioritization & workflow management

Formation

BA/BS in scientific/engineering/healthcare/business

Advanced degree or PM certification preferred

Description du poste

Moderna Therapeutics is seeking a Senior Manager, GRS Integration to support multiple development and commercial programs within Global Regulatory Science. You will translate regulatory strategy into coordinated plans, manage milestones, and partner across GRLs, Country Regulatory Leads, and CMC teams to ensure timely submissions and regulatory commitments.

You will lead planning discussions, manage trackers and dashboards, and proactively identify risks while driving cross-program enhancements