Global Regulatory Strategy Director - Infectious Diseases

Moderna; Bethesda (MD); Hybrid; USD 197,000 - 353,000; Full time

Benefits offered by this job

Healthcare coverage

Well-being programs

Parental support

Generous PTO

Job summary

Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy programs based at Cambridge headquarters or a Moderna East Coast hub.

This role targets a forward-looking regulatory strategist able to anticipate challenges in gaining market approval for mRNA infectious disease vaccines and to articulate clear regulatory strategies across global agencies. The leader will manage a team of regulatory strategists, direct global submissions (CTD), and align with business

Qualifications

• 12+ years in the Pharmaceutical industry.
• 8+ years Regulatory strategy, including Vaccine Development.
• Expert knowledge of FDA, EU, ICH guidelines and regulations for Infectious Disease vaccine programs.
• Strong experience with CTD format and content regulatory filings.
• Experience developing and implementing competitive regulatory strategies.
• Track record of securing product approvals and managing complex portfolios.

Responsibilities

• Sets strategic direction for regulatory submissions and amendments.
• Advises project teams on regulatory strategy through development processes.
• Identifies regulatory risks and responds to regulatory developments.
• Maintains relationships with global health agencies and negotiates with authorities.
• Reviews data and ensures accuracy of regulatory deliverables.
• Leads regulatory submissions and manages timelines with internal teams.

Skills

Regulatory strategy

Leadership

Cross-functional collaboration

Regulatory filings

Strategic thinking

Communication

Team management

Education

Bachelor's degree in science/engineering

Advanced degree preferred

Job description

Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy programs based at Cambridge headquarters or a Moderna East Coast hub.

This role targets a forward-looking regulatory strategist able to anticipate challenges in gaining market approval for mRNA infectious disease vaccines and to articulate clear regulatory strategies across global agencies. The leader will manage a team of regulatory strategists, direct global submissions (CTD), and align with business