Global Regulatory Strategy Lead — Infectious Disease Vaccines

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

Job summary

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

This strategic leader will craft global regulatory plans for mRNA infectious disease vaccines, coordinating with Regulatory Affairs, RA CMC, and cross-functional teams to address challenges and opportunities. The role requires 12+ years in pharma with vaccine regulatory experience, a track record of approvals, and strong communication with health

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.
• Proven track record in securing product approvals and managing complex portfolios.
• Experience leading regulatory authority meetings in different phases of drug development.
• Ability to lead cross-functional teams and manage multiple projects.
• Excellent verbal and written communication skills.

Responsibilities

• Sets strategic direction and leads regulatory submissions content and amendments.
• Advises teams on regulatory strategy through clinical and nonclinical development.
• Identifies regulatory risks and responds to new developments.
• Maintains relationships with global health agencies and negotiates with authorities.
• Reviews data partnerships and ensures accuracy of clinical data for filings.
• Collaborates with internal and external partners to meet milestones.

Skills

Regulatory strategy leadership

FDA/EU/ICH guidelines

CTD filings

Vaccine development

Cross-functional collaboration

Regulatory authority meetings

Global regulatory strategy

Mentoring/regulatory team

Education

BA/BS in science/engineering

Advanced degree preferred

Job description

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

This strategic leader will craft global regulatory plans for mRNA infectious disease vaccines, coordinating with Regulatory Affairs, RA CMC, and cross-functional teams to address challenges and opportunities. The role requires 12+ years in pharma with vaccine regulatory experience, a track record of approvals, and strong communication with health