Regulatory Strategy Manager

4 weeks ago


Bethesda, Maryland, United States Moderna Full time

Job Summary

Moderna is seeking a highly skilled Regulatory Strategy Manager to provide regulatory support for programs within the COVID-19 franchise. The ideal candidate will have a strong background in regulatory strategy and operations, with experience in managing INDs, marketing applications, and other regulatory submissions.

Key Responsibilities

  • Manage regulatory submissions, including INDs, marketing applications, and other regulatory documents
  • Work with global regulatory lead(s), regulatory strategists, and project teams to develop and execute regulatory strategy
  • Coordinate and develop content for 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 for 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 experience with CTD format and content of regulatory filings
  • Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance

What We Offer

  • Highly competitive and inclusive medical, dental and vision coverage options
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
  • Exclusive preferred pricing on Peloton fitness equipment
  • Dedicated care coordination support for our LGBTQ+ community
  • Vacation, sick time and holidays

About Moderna

Moderna is a 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.

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 US. 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.

Equal Employment Opportunity

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.



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