About the Job

The Associate Director, Regulatory Affairs works as part of a new product team, focused on improving blood-based cancer diagnostic capabilities in areas such as cancer detection, minimum residual disease, and other related applications. This team is comprised of talent from across the Roche ecosystem, including Roche Diagnostics, Roche Pharma and Foundation Medicine, operating as a single unit.

The Associate Director, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities) for FMI products. FMI’s products include diagnostic assays that provide molecular insights to physicians to guide treatment options for cancer patients. The incumbent functions as the regulatory representative on cross-functional teams and will be preparing and submitting packages to the FDA for approval of new products or new companion diagnostic indications. The incumbent will actively support the development of regulatory strategy focused on the use of NGS technology for companion diagnostic assays for cancer patients. The incumbent will be responsible for leading a team of 3-5 employees. This position partners closely with product development teams and external partners focused on development of genomic biomarkers and companion diagnostic indications.

Key Responsibilities

• Manage premarket submissions for regulatory approval of in vitro companion diagnostic medical devices in the US market.
• Develop regulatory strategy with oversight for complex projects, including internal FMI projects as well as biopharma partner projects.
• Develop and implement regulatory strategy for non-clinical product development and clinical development.
• Provide regulatory support for currently marketed products, e.g., review engineering changes, labeling, promotional material, product change control documentation to ensure compliance with federal regulations and health authority guidance, including for changes requiring regulatory agency approval or notification, as pertains to US regulatory requirements.
• Represent FMI in interactions with external partners for companion diagnostic development or support for partner drug filings.
• Review and edit technical documents to be included in submission, which may include validation protocols and reports and/or other development documentation.
• Author regulatory submission documentation, including SRDs, IDEs, and PMAs.
• 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 submission (e.g. SRDs, IDEs, Pre-Submissions, PMA).
• Acquire and maintain current knowledge of applicable regulatory requirements, scientific and technical issues in the discipline as relevant to assigned projects.
• Interpret and apply FDA regulations and guidance documents to business practices, evaluating risk and proposing solutions to business challenges based on regulatory strategy.
• Interface with regulatory authorities on regulatory and technical matters as directed, including lead meetings with the regulatory authorities.
• 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 and 6+ years of experience in life sciences, biopharmaceutical, medical device, biologics regulatory or closely related field, OR
• Advanced Degree (Master’s or Doctorate Degree) in science, law, health policy, regulatory affairs or engineering and 4+ years of experience in life sciences, biopharmaceutical, medical device, biologics regulatory or closely related field OR 
• 12+ years of industry experience (pharmaceutical, medical device, or biologics). 
• Experience in regulatory affairs

Preferred Qualifications:

• Advanced degree in science, law, health policy, regulatory affairs or engineering
• 8+ year of regulatory experience 
• Ability to understand and interpret clinical data
• Expert understanding of FDA promotional regulations and reports on post marketing requirements
• Excellent oral and written communication and negotiation skills with strong attention to detail and clarity
• Ability to interact effectively and influence across relevant functions within Ipsen and with regulators
• Demonstrate understanding of commercial objectives of the company and how outcomes can be delivered while meeting FDA compliance standards
• Recognized as a leader, team player, and possess a cross-functional collaborative skill set
• Ability to manage multiple activities or projects
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to reflect FMI's values: Passion, Patients, Innovation, and Collaboration

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