Director of Regulatory Strategy for Latent Viruses mRNA Vaccines

4 weeks ago

Cambridge, Massachusetts, United States Moderna Full time
The Opportunity:

Moderna is seeking a Director of Regulatory Strategy to lead the development and implementation of global regulatory strategy for our Latent Viruses mRNA vaccines. As a key member of our Global Regulatory Science team, you will be responsible for articulating clear and compelling regulatory strategy, highlighting risks and opportunities, and leveraging our mRNA platform technology.

Key Responsibilities:
  • Develop and implement global regulatory strategy for Latent Viruses mRNA vaccines, ensuring alignment with business objectives and negotiation with relevant health authorities.
  • Advise project teams on regulatory strategy through all stages of product development, ensuring regulatory risk assessment and mitigation plans are developed and aligned across functions.
  • Set strategic direction and oversee the preparation, submission, and follow-up of regulatory documents to health authorities.
  • Liaise with health authorities, internal stakeholders, and external partners to ensure business objectives are achieved.
  • Respond to requests for additional data, organize and manage participation in meetings, and negotiate directly with health agencies.
  • Review and approve regulatory documents and dossiers prior to submission to regulatory authorities.
  • Support the development and maintenance of the Target Label Profile and the Company Core Data Sheet.
  • Monitor and interpret changes in the regulatory environment, especially related to the mRNA platform, and communicate potential impact to internal teams.
  • Identify areas for improvement and lead the development and implementation of process improvements.
Requirements:
  • BA/BS degree in a scientific/engineering discipline, advanced degree preferred.
  • 10+ years of experience in the Pharmaceutical industry, 6+ years in Regulatory strategy, including vaccine development.
  • Expert knowledge of relevant FDA, EU, ICH guidelines and regulations related to Infectious Disease vaccine programs.
  • Strong experience with CTD format and content of regulatory filings.
  • Experience with developing and implementing competitive regulatory strategies.
  • Demonstrated track record in maintaining a complex portfolio.
  • Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration.
  • Direct experience of leading regulatory authority meetings in different phases of drug development.
  • Regulatory knowledge across therapeutic areas, including infectious diseases and vaccine development.
About Moderna:

Moderna is a leading biotechnology company that aspires to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. We champion the significant benefits of in-office collaboration by embracing a 70/30 work model, fostering a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

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