Senior Director, Regulatory Strategy - Infectious Disease

Moderna Therapeutics; Cambridge, Northern (MA, KY); Hybrid; USD 197,000 - 353,000; Full time

Benefits offered by this job

Competitive benefits

Equity eligibility

Job summary

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

The role requires strategic leadership across global health agencies, expert regulatory knowledge, and a track record of securing approvals in a fast-paced environment. You will oversee submissions, mentor a team, and collaborate with cross-functional partners to align regulatory plans with business objectives and product

Qualifications

• BA/BS degree in a scientific/engineering discipline; advanced degree preferred.
• 12+ years of experience in the pharmaceutical industry.
• 8+ years in regulatory strategy including vaccine development.
• Expert knowledge of FDA, EU, ICH guidelines for infectious disease vaccines.
• Strong experience with CTD format and regulatory filings.
• Experience developing and implementing competitive regulatory strategies.
• Proven track record of securing product approvals with complex portfolios.
• Knowledge of regulatory procedures for US and EU; cross‑regional experience.
• Direct experience leading regulatory authority meetings in drug development.

Responsibilities

• Sets strategic direction and leads regulatory submissions and amendments.
• Advises project teams on regulatory strategy across clinical and nonclinical development.
• Conducts risk assessments and identifies regulatory concerns; responds to regulatory developments.
• Monitors regulatory developments related to mRNA vaccines and advises on strategy.
• Represents regulatory affairs with global health agencies; maintains relationships.
• Negotiates with health authorities regarding filings and data requests.
• Reviews technical data with RA/CMC and ensures accuracy of filings.
• Collaborates with internal teams and Moderna partners to manage submissions.

Skills

Regulatory strategy

Vaccine development

FDA guidelines

ICH guidelines

CTD filings

Leadership

Global regulatory

Stakeholder negotiation

Education

Bachelor's degree

Advanced degree preferred

Job description

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

The role requires strategic leadership across global health agencies, expert regulatory knowledge, and a track record of securing approvals in a fast-paced environment. You will oversee submissions, mentor a team, and collaborate with cross-functional partners to align regulatory plans with business objectives and product