Person, Text, Face

 

The Research and Development team at Foundation Medicine is constantly pushing the envelope to transform cancer care.

Watch the video above to see how each member has the chance to make a real impact. 

 

Senior Manager, Regulatory Affairs (Data Products)

  • Second Street, Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Senior Manager, Regulatory Affairs 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

• 4+ years of regulatory experience in the device, pharmaceutical/biologics, or other life science industry (including 2+ years in regulatory affairs with software and databases)

 

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

• Data science, computer science, engineering or related field background

• Ability to understand and interpret clinical data

• 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

 

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

Apply Now

Internal applicants, please use your FMI email address.

Please let me know about more jobs like this

Not You?

Thank you

Recommended Jobs

Manager, People Strategy and Talent Acquisition (m/f/d)

People Team 100851 Penzberg, Bavaria DE Germany Penzberg, Bavaria DE, Germany, 82377 Corporate
About the Job The People Strategy & Talent Acquisition Manager (PSTAM), in partnership with the People Strategy Leaders (PSL) and Talent Acquisition Team, operationalizes the people strategy in the business unit to support achievement of stra...

Scientific Copy Editor

Translational Oncology and Clinical Reporting 100804 Cambridge Massachusetts United States Second Street, Cambridge, Massachusetts, United States Operations
About the Job Job Summary The Scientific Copy Editor is integrated within a team of scientists to carry out scientific editing tasks, organizational tasks, operational tasks, and literature research in support of Foundation Medicine’s medical re...

Senior Product Manager

Engineering 100588 Boston Massachusetts United States Seaport Blvd., Boston, Massachusetts, United States Technology
About the Job The Sr. Product Manager, Lab Systems is a specialist position within the Lab Systems team. This position is going lead the transformational project to implement Next Gen lab systems at all FMI lab locations. The incumbent assists wi...

Regulatory Affairs Specialist

Regulatory 100825 Cambridge Massachusetts United States Second Street, Cambridge, Massachusetts, United States R&D
About the Job The Regulatory Affairs Specialist performs activities to support the regulatory submissions process through development of regulatory strategy and submission of materials to the FDA for approval of novel platforms. The position prep...

Send to a friend

Not You?

Thank you for sending this job to your friend.

Clothing, Apparel, Person, Scarf, Finger, Plant, Sitting, Female
Lab, Apparel, Clothing, Person, Scientist, Coat, Lab Coat

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)

To all recruitment agencies: Foundation Medicine does not accept agency resumes. Please do not forward resumes to our jobs alias, Foundation Medicine employees or any other organization location. Foundation Medicine is not responsible for any fees related to unsolicited resumes.