Senior Director, Regulatory Integration Lead (Respiratory Vaccines Unit) - Global Regulatory Sciences

The Role:

Moderna is a global leader in vaccine development, dedicated to advancing innovative solutions for respiratory infectious diseases. We are seeking a Senior Director Regulatory Integration Lead within Respiratory Vaccines Unit to support the integration across programs, functions and geographies of the regulatory strategy for respiratory vaccines and provide high-level coordination between global regulatory product development and local manufacturing site regulatory activities.

The Senior Director Regulatory Integration Lead will serve as a strategic partner to the Head of Regulatory Respiratory Vaccines Unit. This individual will focus on strategic planning and execution, competitive intelligence & product labeling, cross-functional leadership and collaboration, and communication.

As Senior Director Regulatory Integration Lead, you will play a critical role in shaping and executing the regulatory strategy across a portfolio of respiratory vaccine programs. Reporting directly to the VP Regulatory for the Respiratory Vaccines Unit, this role is designed for an experienced regulatory professional to lead strategic initiatives that bridge global regulatory product development with local regulatory and manufacturing site activities.

Here's What You’ll Do:

Strategic Planning & Execution:

• Support the Head of RV Unit to shape and implement regulatory strategies for the respiratory vaccines portfolio, focusing on both single-component and combination respiratory vaccines.

• Ensure strategic alignment across regulatory functions (regulatory strategy, CMC, operations, labeling) with organizational goals.

• Lead high-level strategic initiatives across the regulatory function, driving cross-functional integration with broader corporate objectives.

Cross-functional Leadership & Collaboration:

• Serve as a liaison between regulatory affairs and Commercial ensuring that regulatory goals are in line with overall business strategies, and providing relevant input into the long range forecast planning.

• Facilitate collaboration between global and local teams to align regulatory submissions with product development and manufacturing schedules.

• Serves as the Respiratory Vaccines Unit point of contact for the Canadian manufacturing site

Stakeholder Management & Communication:

• Ensure effective communication between the regulatory affairs team and internal stakeholders, providing regular updates on regulatory activities, timelines, and strategic priorities.

• Prepare executive-level reports, presentations, and briefings for senior leadership.

• Coordinate high-level regulatory meetings, ensuring preparedness and follow-up on key actions.

Here’s What You’ll Need (Minimum Qualifications):

• Education: Bachelor’s degree in Regulatory Affairs, Life Sciences, or a related field; an advanced degree (e.g., MS, Ph.D., PharmD, MBA) is preferred.

• Experience: Minimum 10 years in the pharmaceutical or biotech industry, with at least 5 years focused on regulatory affairs within vaccines or infectious diseases.

• Leadership: Proven ability to lead cross-functional teams, aligning regulatory strategy with corporate and manufacturing goals.

• Analytical & Communication Skills: Demonstrated experience in preparing executive-level reports, with strong communication and analytical skills to convey regulatory priorities effectively.

Here’s What You’ll Bring to the Table (Preferred Qualifications):

• Advanced Degree: Master’s, Ph.D., or PharmD in Regulatory Affairs or a related field.

• Cross-functional Collaboration: Experience working across regulatory strategy, commercial, and manufacturing functions.

• Strategic & Competitive Insight: Proven ability to incorporate competitive intelligence and long-range planning into regulatory strategy.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
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