Sr. Manager, GRS Integration

The Role:

Moderna is seeking a Senior Manager, GRS Integration to support assigned development and/or marketed programs within Global Regulatory Science. This role may support more than one program at a time based on business priorities, program needs, and team capacity.

The Senior Manager, GRS Integration will work closely with Global Regulatory Leads (GRLs), Country Regulatory Leads, Regulatory CMC Leads, and other regulatory and cross-functional partners to support the planning, coordination, and execution of regulatory activities across assigned programs. The role is responsible for helping translate regulatory strategy and program priorities into coordinated plans, timelines, milestones, and deliverables, while maintaining visibility to dependencies, risks, and upcoming regulatory commitments.

This role requires strong project and program management capabilities, effective partnership, sound judgment, and the ability to manage multiple priorities in a matrixed environment. The Senior Manager will actively manage regulatory plans and activities in partnership with program regulatory leadership, helping ensure that teams remain aligned, actions are followed through, risks are surfaced appropriately, and regulatory milestones progress as planned.

Here’s

What You’ll Do:

Support one or more assigned programs, partnering closely with Global Regulatory Leads, Country Regulatory Leads, Regulatory CMC Leads, and other regulatory team members to develop, maintain, and execute integrated regulatory plans.

Translate agreed regulatory strategy and program priorities into actionable plans, milestones, deliverables, timelines, dependencies, and ownership, ensuring regulatory activities remain coordinated across development, registration, and post-marketing stages.

Actively manage regulatory plans, trackers, dashboards, and related planning tools to maintain current and accurate visibility into program milestones, risks, deliverables, dependencies, and upcoming decision points.

Facilitate regulatory team meetings and planning discussions, ensuring decisions, risks, actions, and follow-up activities are clearly captured, assigned, and progressed.

Proactively identify timeline risks, gaps, dependencies, and operational challenges; partner with regulatory leads to assess impacts, develop mitigation plans, support scenario planning, and escalate issues when appropriate.

Support planning and readiness for major regulatory activities, including submissions, health authority interactions, responses to questions, CMC regulatory activities and variations, and country-specific regulatory requirements.

Contribute to continuous improvement and cross-program initiatives that strengthen GRS Integration processes, tools, data quality, planning practices, visibility, and operational consistency.

Here’s

What You’ll Bring to the Table:

BA/BS degree 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 the pharmaceutical, biotechnology, or related life sciences industry, with relevant experience in regulatory project/program management, regulatory operations, drug development, or a closely related function.

Experience supporting regulatory planning and execution across one or more stages of product development, registration, and/or post-marketing activities.

Understanding of regulatory development processes and the activities required to support regulatory submissions, health authority interactions, approvals, and ongoing regulatory commitments.

Knowledge of U.S. regulatory requirements with exposure to international regulatory requirements and global development activities.

Demonstrated…