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Director, Regulatory Affairs

  • Cambridge, Massachusetts, United States
  • Full Time

ABOUT THE JOB

The Director, Regulatory Affairs is responsible for leading the international regulatory function and its activities, the development of international regulatory strategy, and for approval and registration of products in countries outside of the US. The incumbent is responsible for ensuring that FMI products are appropriately registered or approved.  This position partners closely with the Commercial team, cross-functional product Lifecycle teams and Roche affiliates outside of the United States.

Key Responsibilities:

  • Ensure that assigned products are developed and validated per regulatory standards.
  • Partner with affiliates to obtain approval and/or registration for international product portfolio.
  • Serve as the internal regulatory expert on international regulatory requirements.
  • Develop regulatory strategy for complex projects.
  • Draft submission documents with other subject matter experts as needed.
  • Prepare and review pre-submission documents, and regulatory submissions.
  • Review and edit technical documents to be included in submission, which may include both assay and software documentation.
  • Speak as subject matter expert with regulatory authorities outside of the US.
  • Interact with external partners for companion diagnostic development.
  • Review change control documentation and ensure appropriate notification process is followed.
  • Supervise and mentor other members of the Regulatory Affairs team.
  • Other duties as assigned. 

QUALIFICATIONS

Basic Qualifications:

  • Bachelor’s Degree.
  • 5+ years of regulatory experience in the device, pharmaceutical/biologics, or other area in the life sciences industry (including 3+ years in regulatory experience with software or databases, if applicable).

Preferred Qualifications:

  • Advanced degree (Master’s Degree or PhD) in applicable regulatory field of study.
  • 8+ years of experience relating to the assigned business function.
  • Ability to understand and interpret clinical data.
  • Expert understanding of international regulatory landscape and requirements for IVDs.
  • Strong technical background in next generation sequencing technologies.
  • Experience in companion diagnostic work.
  • Expertise in regulatory strategy.
  • History of successfully managing multiple concurrent regulatory submissions.
  • Strong attention to detail and organizational skills.
  • Ability to influence across relevant functions and with regulators.
  • Demonstrated ability to meet project deadlines.
  • Excellent interpersonal skills including strong written and verbal communication, collaboration, and problem solving with a variety of audiences.
  • Understanding of HIPAA and importance of patient data privacy.
  • Commitment to FMI’s values: innovation, patients, collaboration, and passion.

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Internal applicants, please use your FMI email address.

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