Global Regulatory Strategy Director, mRNA Vaccines

Moderna; Cambridge (MA); Sur place; USD 250 000 - 340 000; Plein temps

Résumé du poste

Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead global regulatory programs from its Cambridge headquarters or East Coast hubs.

The role focuses on gaining market approval for mRNA infectious disease vaccines, leveraging global health agency interactions and regulatory expertise. The Sr. Director will guide regulatory strategy, manage submissions, and coordinate with internal teams to ensure successful development and approvals while navigating US and EU requirements and

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 and regulations for Infectious Disease vaccine programs.
• Strong experience with CTD format and content regulatory filings.
• Experience developing and implementing competitive regulatory strategies.
• Proven track record securing product approvals and managing a complex portfolio.
• Knowledge of regulatory procedures for US and EU drug development and registrations.
• Direct experience leading regulatory authority meetings.

Responsabilités

• Sets strategic direction and leads regulatory submissions and related supplements and amendments.
• Advises project teams on regulatory strategy through development processes.
• Identifies regulatory risks and responds to new government developments.
• Monitors regulatory developments related to mRNA vaccine programs.
• Maintains relationships with global health agencies and negotiates with authorities.
• Reviews technical data and verifies accuracy of clinical data for filings.
• Helps plan trials and filing activities and ensures report systems are compliant.
• Collaborates with internal teams and Moderna partners to manage submissions.

Connaissances

Regulatory strategy

FDA regulations

EU regulations

Vaccine development

CTD format

Cross-functional leadership

Formation

BA/BS in science or engineering

Advanced degree preferred

Outils

CTD format

Description du poste

Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead global regulatory programs from its Cambridge headquarters or East Coast hubs.

The role focuses on gaining market approval for mRNA infectious disease vaccines, leveraging global health agency interactions and regulatory expertise. The Sr. Director will guide regulatory strategy, manage submissions, and coordinate with internal teams to ensure successful development and approvals while navigating US and EU requirements and