About the Job

The Regulatory Affairs Sr Mgr is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process for FMI data products or platforms that leverage data from those products. The incumbent functions as the regulatory representative on cross-functional teams as well as prepares and submits packages to regulatory authorities for approval of data products and software. The position actively supports the development of regulatory strategy focused on the use of genomics data, including real world clinico-genomic data, AI/ML algorithms, SaMDs and CDSs to support the cancer patient journey. Additionally, this position partners closely with product development teams and external partners focused on development of FMI data products or platforms that leverage data from those products.

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).
• Manage pre-market submissions for regulatory approval of data products.
• Manage internal and external communications focused on regulatory considerations for data products, including real world data (RWD), AI/ML algorithms, SaMDs and CDSs.
• 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 submissions, 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.
• Represent FMI in FDA interactions including telephone calls 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 support filing of appropriate FDA notification (sPMA, 30-day notice, etc.).
• Partner 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.
• Manage and mentor junior members of the Regulatory Affairs Team.
• Represent Regulatory Affairs department at cross-functional internal project meetings.
• May perform other duties as required or assigned.

Qualifications

Basic Qualifications

• Bachelor’s Degree
• 5+ years of regulatory experience in the device, pharmaceutical/biologics, biotech, or other life science industry (including 3+ years in regulatory affairs) 

Preferred Qualifications

• 3+ years of experience in regulatory affairs within the data product industry
• Advanced Degree (Master’s or Doctorate) in data science, engineering or closely related field
• Ability to understand and interpret clinical data
• Understanding of appropriate standards and guidances pertaining to software development life cycle (SDLC)
• Understanding of FDA software / digital health guidances and use of RWE in regulatory submissions
• Strong knowledge of FDA, EMA, PMDA regulatory process
• History of effective time management, organization, prioritization and multitasking
• History of proactive and independent problem solving
• History of successfully managing multiple concurrent regulatory submissions
• Technical background in next generation sequencing technologies
• Experience in companion diagnostic work
• Strong attention to detail and organizational skills
• Effective and clear oral and written communication skills, and negotiation skills
• Strong collaborative skill set, demonstrated by creative and effective contributions in cross-functional or cross-departmental partnerships 
• 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

#LI-Hybrid