Associate Director of Regulatory Affairs, Precision Medicine

2 months ago

New York, United States NavitsPartners Full time
Job DescriptionJob Description

Job Title: Associate Director of Regulatory Affairs, Precision Medicine & Digital Health
Location: Remote

Please ensure that your candidate's resume demonstrates the requirements listed below.

Must-Have List:

  1. In vitro diagnostics regulations in precision medicine under US and EU regulations.
  2. Experience with drug trials that use a biomarker to select patients, including but not limited to:
    • Understanding Clinical Trial Assay (CTA) requirements with diagnostic partners.
    • Knowledge of sample testing/shipping regulations in different countries.
    • Companion Diagnostic (CDx) development requirements.
  3. Experience in building a diagnostic device regulatory strategy plan for a biomarker-driven trial.
  4. Up-to-date knowledge of Digital Health technology regulatory requirements and experience working on a digital pathology or digital health product in a drug development setting.

Position Responsibilities:

  • Provide leadership for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health, and other devices to enhance the value of pharmaceutical products across therapeutic areas.
  • Understand the regulatory landscape, assess regulatory risks, and develop global filing strategies.
  • Co-lead marketing application submission teams for indications at the regulatory filing stage to develop content strategy for global dossiers.
  • Ensure consistent positions are presented in responses to global Health Authority (HA) queries.
  • Ensure global development plans meet global regulatory requirements by integrating regional regulatory strategy input.
  • Collaborate with the Global Regulatory sub-team to develop global submission plans and HA interaction plans.
  • Provide input into the development of protocol synopses and protocols.
  • Contribute to cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.
  • Contribute to the development of target labeling.

Degree / Experience Requirements:

  • Bachelor’s degree required; advanced scientific degree preferred (e.g., Masters, PhD, PharmD, BSN) with at least 5 years in the industry, including at least 4+ years of US Medical Device Regulatory Affairs experience.

Key Competencies:

  • Proven experience in leading teams and representing regulatory functions on project teams within the client organization and across alliances.
  • Experience in developing regulatory strategies aligned with clinical plans and marketing objectives.
  • Experience with clinical trial assays (CTA) in drug clinical trials, including communication between Diagnostic sponsors and Drug sponsors.
  • Experience as a member of Global Regulatory sub-teams, project working groups, or comparable industry experience, including coordinating communications within teams and across functions.
  • Proficiency in communicating regulatory strategies, issues, and risks in written and verbal formats to governing bodies.
  • Ability to apply project management techniques within teams and effectively manage meetings.
  • Demonstrated ability to breakdown complex scientific content into logical components.
  • Ability to coordinate global activities, facilitate issue resolution, and manage conflicts.
  • Demonstrated ability to drive quality decision-making and organize/prioritize tasks.
  • Strong negotiation and influence skills.
  • Understanding of strategic and tactical roles in the drug development process.
  • Understanding of general global regulatory requirements for drugs in development.
  • Knowledge of the R&D process and specific regulatory responsibilities/deliverables for company decision points.

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