Senior Director, Regulatory Project Management

The Role:

Managing a team of up to 14 Regulatory Project Managers, the Regulatory Project Management Lead will build, develop, and oversee a high-performing regulatory project management team. This individual will manage team members, provide strategic guidance, and ensure regulatory projects are executed efficiently and in compliance with global standards. In addition to hands-on project oversight, this role will enhance the project management framework, developing processes and best practices that support regulatory excellence and continuous improvement.

Here's What You’ll Do:

Build and Develop Regulatory Project Management Capability:

• Establish a robust regulatory project management framework, incorporating industry best practices, tools, and processes.

• Design and implement training programs to enhance the team’s project management skills and regulatory knowledge.

• Develop resource management and planning capabilities to support scalability and project efficiency across the organization.

• Resourcing model for deployment of RPMs to drug projects

Team Leadership and Line Management:

• Lead, mentor, and support a team of regulatory project managers, setting performance standards and development goals.

• Conduct regular performance evaluations, offering guidance and support for career growth and technical skill enhancement.

• Oversee resource allocation to balance team workloads and optimize project delivery.

Strategic Project Oversight:

• Guide the team in defining regulatory project strategies, ensuring alignment with company objectives and regulatory timelines.

• Oversee preparation and submission of regulatory filings (e.g., INDs, NDAs, MAAs) to ensure compliance and timely delivery.

• Serve as an escalation point for complex regulatory challenges, providing direction to project managers as needed.

Regulatory Compliance and Best Practice Implementation:

• Ensure adherence to FDA, EMA, ICH, and other global regulatory standards across all projects.

• Drive the implementation of best practices for regulatory project management, maintaining consistency and efficiency.

• Monitor regulatory landscape changes, updating team processes and training to align with evolving guidelines.

Stakeholder Engagement and Communication:

• Act as a liaison between the regulatory project management team and other departments, ensuring clear communication and optimal collaboration.

• Provide regular updates to senior management on project timelines, risks, and achievements.

• Lead cross-functional meetings to facilitate project progress and stakeholder alignment.

Continuous Improvement and Process Optimization:

• Identify and implement process improvements to enhance regulatory project management efficiency. Including identification of digital tools for RPM and submission efficiency and acceleration. (KPIs)

• Regularly review team performance metrics and outcomes, adjusting strategies as needed to improve efficiency and quality.

• Stay current with industry trends, sharing insights with the team to drive continuous improvement.

Here’s What You’ll Bring to the Table:

• Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or related field; advanced degree preferred.

• Minimum of 8 years of experience in regulatory affairs or project management within the pharmaceutical/biotechnology industry, including 3+ years in a leadership role.

• Expertise in global regulatory submissions and familiarity with FDA, EMA, and ICH guidelines.

• Demonstrated experience in building and leading high-performing project management teams.

• Strong organizational, communication, and problem-solving skills, with a focus on continuous improvement.

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