Global Regulatory Lead, mRNA Vaccine Strategy

Moderna Therapeutics; Cambridge (MA); On-site; USD 197,000 - 353,000; Full time

Benefits offered by this job

Competitive healthcare

Discretionary bonus eligibility

Generous time off

Job summary

Moderna, Inc. seeks a Sr. Director of Regulatory Strategy to lead global regulatory plans for infectious disease vaccines from its Cambridge headquarters or East Coast hubs.

You will articulate clear regulatory pathways, align with health authorities, and drive submissions across development stages in a fast-paced, matrix environment. The role demands 12+ years in pharma, 8+ in regulatory strategy, strong FDA/EU/ICH knowledge, and proven leadership of cross‑functional teams and regulatory

Qualifications

• 12+ years of experience in the pharmaceutical industry.
• 8+ years in regulatory strategy, including vaccine development.
• Expert knowledge of FDA, EU, ICH guidelines and regulations for infectious disease vaccines.
• Experience leading regulatory authority meetings and global submissions.

Responsibilities

• Set strategic direction for regulatory submissions and related documents.
• Advise project teams on regulatory strategy across development stages.
• Monitor regulatory developments and manage risks and gaps.
• Lead global regulatory development plans and liaise with health agencies.
• Manage resources and budget for regulatory projects.

Skills

Regulatory strategy

Vaccine development

FDA/EU/ICH knowledge

CTD submissions

Project leadership

Stakeholder management

Cross-functional collaboration

Regulatory authority meetings

Team leadership

Regulatory planning

Education

BA/BS in a scientific/engineering discipline

Advanced degree preferred

Tools

CTD format

Job description

Moderna, Inc. seeks a Sr. Director of Regulatory Strategy to lead global regulatory plans for infectious disease vaccines from its Cambridge headquarters or East Coast hubs.

You will articulate clear regulatory pathways, align with health authorities, and drive submissions across development stages in a fast-paced, matrix environment. The role demands 12+ years in pharma, 8+ in regulatory strategy, strong FDA/EU/ICH knowledge, and proven leadership of cross‑functional teams and regulatory