Global Reg Strategy Director, Vaccines & mRNA

Regulatory Jobs; Cambridge (MA); Hybrid; USD 197,000 - 353,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning benefits

Generous paid time off

Savings and investments

Location-specific perks

Job summary

Moderna, Inc. seeks a Sr. Director of Regulatory Strategy to lead regulatory programs from its Cambridge headquarters or East Coast hubs.

The role demands a forward-looking regulatory strategist to drive market approvals for mRNA vaccines, with accountability for global regulatory development plans and cross-functional collaboration. Ideal candidates have extensive regulatory experience in infectious disease vaccine programs, strong leadership skills, and a track record of successful regulatory

Qualifications

• Broad knowledge of FDA, EU, ICH guidelines for Infectious Disease vaccines.
• Experience leading regulatory authority meetings.
• Delivery of major regulatory submissions (NDA/BLA/MAA).
• Ability to work independently in a fast-paced environment.
• Strong communication and leadership in cross-functional teams.
• Experience with US and EU regulatory procedures.

Responsibilities

• Set strategic direction for regulatory submissions and related supplements.
• Advise project teams on regulatory strategy through development stages.
• Conduct risk assessments and identify regulatory concerns.
• Monitor mRNA vaccine regulatory developments and advise teams.
• Build and maintain relationships with global health agencies.
• Negotiate with health authorities regarding filings.
• Review data with RA/CMC and ensure accuracy of clinical data.
• Collaborate with internal teams and Moderna partners on submissions.
• Lead global regulatory development plans for assigned projects.
• Identify process improvements and manage resources for projects.
• Supervise Regulatory strategy team for COVID programs.

Skills

Regulatory strategy leadership

Vaccine development regulatory

FDA/EU/ICH guidelines

CTD filings

Regulatory submissions

Cross-functional collaboration

Project management

Leadership/people management

Communication skills

Regulatory meetings with authorities

Education

BA/BS in science/engineering

Advanced degree preferred

Job description

Moderna, Inc. seeks a Sr. Director of Regulatory Strategy to lead regulatory programs from its Cambridge headquarters or East Coast hubs.

The role demands a forward-looking regulatory strategist to drive market approvals for mRNA vaccines, with accountability for global regulatory development plans and cross-functional collaboration. Ideal candidates have extensive regulatory experience in infectious disease vaccine programs, strong leadership skills, and a track record of successful regulatory