Global Regulatory Strategy Lead, Infectious Disease Vaccines

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

Benefits offered by this job

Competitive healthcare

In-office culture and mentorship

Global impact in mRNA vaccine programs

Job summary

Moderna, Inc. in Cambridge, MA, seeks a Sr. Director of Regulatory Strategy to lead regulatory plans for mRNA vaccines, partnering across Global Regulatory Science to anticipate and address market approvals worldwide.

This senior role requires deep regulatory expertise, global agency negotiations, and the ability to direct cross-functional teams, ensuring alignment with business objectives and delivering timely filings.

Qualifications

• 12+ years of experience in the Pharmaceutical industry.
• 8+ years of experience in Regulatory strategy, including Vaccine Development.
• Expert knowledge of FDA, EU, ICH guidelines for Infectious Disease vaccine programs.
• Strong CTD format and regulatory filings knowledge.
• Demonstrated track record in securing product approvals and managing complex portfolios.
• Experience leading regulatory authority meetings across drug development.

Responsibilities

• Set strategic direction and lead regulatory submissions and amendments.
• Advise project teams on regulatory strategy through development processes.
• Monitor regulatory developments and identify risks and regulatory concerns.
• Lead global regulatory discussions with health agencies and partners.
• Establish and maintain relationships with global health authorities.
• Manage data requests and coordinate meetings with health agencies.
• Provide input on trials and filing activities and ensure compliant report systems.
• Collaborate with cross-functional teams to develop content and manage submissions.

Skills

Regulatory strategy

Vaccine development

Cross-functional leadership

Regulatory submissions

Communication skills

Project management

Stakeholder management

Education

BA/BS in a scientific discipline

Advanced degree preferred

Tools

CTD format

Regulatory databases

Job description

Moderna, Inc. in Cambridge, MA, seeks a Sr. Director of Regulatory Strategy to lead regulatory plans for mRNA vaccines, partnering across Global Regulatory Science to anticipate and address market approvals worldwide.

This senior role requires deep regulatory expertise, global agency negotiations, and the ability to direct cross-functional teams, ensuring alignment with business objectives and delivering timely filings.