Associate Director, Global Regulatory Strategy, Oncology

1 week ago

Cambridge, Massachusetts, United States Moderna Full time
About the Role

Moderna Therapeutics is seeking an experienced Associate Director to lead the development and execution of regulatory strategies for the oncology franchise. As a key member of the Global Regulatory Strategy team, you will be responsible for setting the strategic direction for the US market and ensuring alignment with global product strategy.

Key Responsibilities
  • Develop and execute regulatory plans for the US market and ex-US regions for assigned programs at various stages of product development.
  • Articulate clear and compelling regulatory strategy and highlight risks and opportunities when appropriate.
  • Lead the strategy for US FDA interactions, including development of content, format, and accountability for regulatory submissions and related supplements and amendments.
  • Conduct risk assessment and identify potential areas of regulatory concern for assigned projects or programs.
  • Collaborate with cross-functional teams to lead the response to health authority requests for additional data and organize participation in meetings relevant to aspects of compound development.
  • Review and approve regulatory documents prior to submission to respective regulatory authority(ies).
  • Serve as primary point of contact and negotiate directly and effectively with FDA and other health agencies for assigned programs.
Requirements
  • BA/BS degree in a scientific/engineering/healthcare discipline required, Masters, PharmD or PhD preferred.
  • 7+ years of experience in the Pharmaceutical industry preferred.
  • 5+ years of experience in Regulatory strategy or relevant training/experience preferred.
  • Experience in oncology therapeutics highly preferred.
  • Demonstrated track record in being a leader on functional and cross-functional teams.
  • Strong knowledge of current US regulations and knowledge of ex-US regulations.
  • Strong experience with CTD format and content of regulatory filings.
  • Exceptional written and oral communication.
  • Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension, and license maintenance at least in the US.
  • Demonstrate strong organizational skills, including the ability to prioritize workload.
About Moderna

Moderna is a leading biotechnology company that is pioneering the use of mRNA technology to develop innovative medicines. We are committed to creating a culture of belonging and building an organization that cares deeply for our patients, employees, the environment, and our communities.

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.

Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship.

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