Senior Director, Global Regulatory Strategy – Infectious Disease

Socket.dev; Cambridge (MA); On-site; USD 197,000 - 353,000; Full time

Job summary

Moderna, Inc. in Cambridge, MA is seeking a Sr. Director of Regulatory Strategy to lead global regulatory programs for an mRNA vaccine portfolio.

You will craft regulatory development plans, influence health authorities, and guide teams through clinical and regulatory filings. The role demands a strategic leader with deep FDA/EU knowledge, a proven track record securing approvals, and the ability to manage cross-functional teams across US and EU.

Qualifications

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

Responsibilities

• Sets strategic direction and leads content and accountability for regulatory submissions and supplements.
• Advises teams on regulatory strategy through clinical and nonclinical development.
• Assesses risks and regulatory concerns; responds to regulatory developments.
• Monitors regulatory developments for the mRNA platform, focusing on vaccines.
• Establishes relationships with global health agencies.
• Negotiates with health agencies regarding filings and data requests.
• Reviews and approves technical data with RA CMC; verifies clinical data accuracy.
• Provides input on trials and filing activities; ensures compliant reporting systems.
• Collaborates with internal teams and Moderna partners to prepare submissions.
• Fosters inclusive environment and cross-functional teamwork.
• Serves as global regulatory lead for assigned projects and develops global plans.
• Ensures regulatory strategy aligns with business objectives and authorities’ negotiations.
• Identifies improvements and leads process enhancements.
• Manages resources, budgets, and regulatory staffing for projects.
• Leads a team of regulatory strategists for COVID-facing programs.

Skills

Regulatory strategy

FDA regulations

EU regulations

Vaccine development

CTD submissions

Leadership

Cross-functional collaboration

Education

BA/BS in scientific/engineering discipline

Advanced degree preferred

Job description

Moderna, Inc. in Cambridge, MA is seeking a Sr. Director of Regulatory Strategy to lead global regulatory programs for an mRNA vaccine portfolio.

You will craft regulatory development plans, influence health authorities, and guide teams through clinical and regulatory filings. The role demands a strategic leader with deep FDA/EU knowledge, a proven track record securing approvals, and the ability to manage cross-functional teams across US and EU.