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Director of Regulatory Affairs, Data Products

Cambridge | Massachusetts | United States

ABOUT FOUNDATION MEDICINE

Foundation Medicine, Inc. (FMI) began with an idea—to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives. 

ABOUT THE JOB

The Director, Regulatory Affairs is responsible for leading the regulatory function and its activities, the development of regulatory strategy, and supporting the regulatory approval process of materials for FMI data products or platforms that leverage data from those products. The position develops regulatory strategy for use of Real-World Evidence (RWE) in drug, device and diagnostic submissions. The incumbent functions as the regulatory subject matter expert for the FMI Data Products team and is embedded within that organization to enable close bidirectional collaboration. This position supports the regulatory approval processes of the US FDA, and may support approval through EMA, PMDA and others.

Key Responsibilities:

  • Ensure that software and data products are developed and validated to standards required for FDA-regulated products and/or for data included as part of a drug or diagnostic regulatory approval submission (e.g. NDA, PMA).
  • Serve as the internal regulatory expert on software and data/database products.
  • Provide internal training as needed on FDA requirements.
  • Develop regulatory strategy for complex projects, including internal FMI regulatory needs as well as biopharma partner regulatory submissions. 
  • Prepare and review FDA submissions including pre-submission documents, Significant Risk Determination Requests, IDE/IND applications, premarket applications (NDA, PMA, BLA) and post-market reporting.
  • Draft submission documents with other subject matter experts as needed.
  • Review and edit technical documents to be included in submission, which may include software validation protocols and reports and/or other software development documentation.
  • Monitor external activities and develop FMI thought leadership around the use of real-world evidence for oncology regulatory use-cases, including for real-world control arms.
  • Lead FDA interactions including telephone calls and and face-to-face meetings.
  • Participate in agency-sponsored working groups around real-world data and evidence.
  • Interact with external partners for companion diagnostic development or support for partner drug filings.
  • Review change control documentation and file appropriate FDA notification (sPMA, 30-day notice, etc).
  • Partners closely with product and software development teams focused on development of real-world data products, including databases that have merged comprehensive genomic profile results with clinical outcome data.
  • Supervise and mentor junior members of the Regulatory Affairs Team.
  • Other duties as assigned. 

QUALIFICATIONS

Basic Qualifications:

  • Bachelor’s Degree and 8+ years of device, pharmaceutical/biologics regulatory, or scientific industry experience including 3+ years in regulatory affairs with software and databases.
  • OR     -
  • Advanced degree in law, health policy, regulatory affairs, engineering or a science and 5+ years of device, pharmaceutical/biologics regulatory, or scientific industry experience including 3+ years in regulatory affairs with software and databases.

Preferred Qualifications:

  • Ability to understand and interpret clinical data.
  • Expert understanding of FDA software guidance and use of RWE in regulatory submissions.
  • Strong knowledge of FDA, EMA, PMDA regulatory process.
  • Expertise in regulatory strategy.
  • Recognized as a leader and team player.
  • History of successfully managing multiple concurrent regulatory submissions.
  • Outstanding interpersonal skills that include excellence in written communication, oral communication, negotiation, collaboration, and problem solving.
  • Excellent cross-functional collaboration skills.
  • Strong attention to detail and organizational skills.
  • Ability to interact effectively and influence across relevant functions
  • Demonstrated ability to meet project deadlines.
  • Understanding of HIPAA and importance of patient data privacy.

Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form.  (EOE/AAP Employer)

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