Global Regulatory Expert

6 days ago


Bethesda, Maryland, United States Moderna Full time
Role Overview

We are seeking a seasoned Sr. Manager to provide regulatory support for our COVID-19 vaccine programs and be based in one of our East Coast hubs. This role involves managing INDs, marketing applications, and other regulatory submissions, as well as coordinating with global regulatory leads and project teams.

About the Job
  • Develop and execute regulatory strategies through the product development lifecycle.
  • Coordinate, develop, and contribute to content and format of regulatory submissions and related supplements and amendments.
  • Identify and assess regulatory risks for assigned projects or programs.
  • Serve as point of contact with regulatory agencies relevant to assigned projects or programs.
Requirements
  • BA/BS degree in a scientific/engineering/healthcare discipline required; Masters, PharmD or PhD preferred.
  • 5+ years of experience in the Pharmaceutical industry preferred.
  • 3+ years of experience in Regulatory strategy or relevant training/experience preferred.
  • Strong knowledge of current US and EU regulations.
  • Experience with CTD format and content of regulatory filings.
  • Exceptional written and oral communication skills.
About Us

At Moderna, we are committed to building a culture of belonging and making a meaningful impact on society. We believe in giving our people a platform to change medicine and an opportunity to change the world. Our team is driven by a passion for innovation and a commitment to excellence.

We offer a competitive salary of $120,000 per year, plus benefits including medical, dental, and vision coverage options, flexible spending accounts, lifestyle spending account funds, family care benefits, and more. We also provide opportunities for professional growth and development, as well as a comprehensive suite of employee benefits.

Our company values diversity, equity, and inclusion, and we strive to create a work environment that is welcoming and inclusive for all employees. If you share our values and are passionate about making a difference in the lives of others, we encourage you to apply.

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