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Senior Manager of Regulatory Affairs

2 months ago

Bethesda, Maryland, United States Moderna Therapeutics Full time
About the Role

Moderna Therapeutics is seeking a highly skilled Regulatory Strategy Manager to join our team in Cambridge, Massachusetts. As a key member of our Clinical Development team, you will play a critical role in shaping our regulatory strategy and ensuring compliance with relevant regulations.

Key Responsibilities
  • Develop and implement regulatory strategies for our oncology products, including INDs, marketing applications, and other regulatory submissions.
  • Collaborate with cross-functional teams to ensure regulatory compliance and provide strategic guidance on regulatory matters.
  • Manage and coordinate regulatory submissions, including drafting and reviewing regulatory documents, and interacting with regulatory agencies as needed.
  • Contribute to the development and implementation of clinical and pre-clinical regulatory strategy for projects in all stages of development.
  • Provide regulatory support for global labeling and maintain the Core Data Sheet.
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.
  • Experience in Oncology is strongly preferred.
  • Strong knowledge of current US and EU regulations.
  • Exceptional written and oral communication skills.
What We Offer
  • Competitive salary range: $125,500 to $201,000.
  • Comprehensive incentive compensation package, including an annual cash bonus, new hire equity, and an annual refresh.
  • 401(k) match and Financial Planning tools.
  • Moderna-paid Life, LTD, and STD insurance coverages, as well as voluntary benefit options.
  • Complimentary concierge service, including home services research, travel booking, and entertainment requests.
  • Free parking or subsidized commuter passes.