Senior Regulatory Program Lead - GRS Integration

Moderna; Cambridge (MA); Hybrid; USD 131,000 - 209,000; Full time

Benefits offered by this job

Competitive healthcare

Annual bonus potential

Equity option

Generous PTO

Job summary

Moderna seeks a Senior Manager, GRS Integration in Cambridge, MA to lead regulatory planning and execution for multiple programs. You will partner with GRLs, Country Regulatory Leads, and CMC teams to translate strategy into integrated plans, manage risks, and ensure timely deliverables across development, registration, and post-marketing stages.

Ideal candidate has 5+ years in regulatory program management within pharma/biotech, strong leadership, and a collaborative mindset.

Qualifications

• BA/BS in a scientific, engineering, healthcare, business, or related discipline required; advanced degree and/or project management certification is a plus.
• Minimum of 5 years of progressive experience in pharma/biotech with regulatory project/program management experience.
• Experience supporting regulatory planning and execution across product development stages.

Responsibilities

• Develop, maintain, and execute integrated regulatory plans for assigned programs.
• Translate regulatory strategy into actionable plans, milestones, and timelines across development, registration, and post-marketing.
• Manage regulatory plans, trackers, dashboards, and planning tools for visibility into milestones and risks.
• Facilitate regulatory team meetings, ensuring decisions and actions are captured and progressed.
• Identify timeline risks and dependencies; work with leads on mitigation plans and scenario planning.
• Support planning for major regulatory activities including submissions and interactions with health authorities.
• Contribute to cross-program improvements in GRS integration processes and data quality.

Skills

Regulatory PM

Cross-functional coordination

Regulatory planning

eCTD submissions

Risk management

Education

BA/BS in science or related

Advanced degree / PM cert is a plus

Tools

MS Project

Job description

Moderna seeks a Senior Manager, GRS Integration in Cambridge, MA to lead regulatory planning and execution for multiple programs. You will partner with GRLs, Country Regulatory Leads, and CMC teams to translate strategy into integrated plans, manage risks, and ensure timely deliverables across development, registration, and post-marketing stages.

Ideal candidate has 5+ years in regulatory program management within pharma/biotech, strong leadership, and a collaborative mindset.