Associate Director, Regulatory Affairs

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 Foundation Medicine products. Foundation Medicines 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. 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 Foundation Medicine 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 Foundation Medicine 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. 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.
Bachelors Degree and 8+ years of experience in life sciences, biopharmaceutical, medical device, biologics regulatory or closely related field, OR
~ Masters Degree in science, law, health policy, regulatory affairs or engineering and 6+ years of experience in life sciences, biopharmaceutical, medical device, biologics regulatory or closely related field OR
~ Doctorate Degree in science, law, health policy, regulatory affairs or engineering and 3+ years of experience in life sciences, biopharmaceutical, medical device, biologics regulatory or closely related field
~4+ years of management experience
~ Experience in regulatory affairs

8+ year of regulatory experience
~ Ability to understand and interpret clinical data
~ Demonstrate understanding of commercial objectives of the company and how outcomes can be delivered while meeting FDA compliance standards
~ Ability to manage multiple activities or projects
~ Understanding of HIPAA and the importance of patient data privacy
~ Commitment to reflect Foundation Medicine's values: The salary range is commensurate with Foundation Medicines compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.
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