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Hybrid Associate Director, Global Regulatory Affairs – Diagnostics

at OneTrust
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About the role

  • Contribute to the development and realization of business objectives by preparing, reviewing, and implementing regulatory strategies for diagnostic products related to the therapeutic product development.
  • Oversee the coordination and compilation of global submissions for (new) In Vitro Diagnostics (IVD) and Medical Devices (MD) to Health Authorities (HAs).
  • Maintain appropriate external contacts and negotiate with HAs (U.S., EU, PMDA, and others) to obtain timely registration of the diagnostic products.
  • Provide guidance, support, and educational training to pharmaceutical project teams regarding in vitro diagnostic regulations and regulatory strategy.
  • Draft and/or review the U.S. and EU Study Risk Determinations for the investigational diagnostic products used in the therapeutic product clinical studies.
  • In partnership with the diagnostic test provider, handle the timely coordination, compilation, and submission of investigational and new in vitro diagnostic medical device applications to the regulatory authorities.
  • Track Requests for Information (RFI) received from regulatory authorities related to diagnostic product submissions and manage the cross-functional responses to the RFI.
  • Communicate with regulatory authorities and notified bodies to expedite approval of diagnostic regulatory submissions.
  • Participate in therapeutic product Global Regulatory Team (GRT) meetings and provide updates to the teams regarding diagnostic product deliverables and timelines.
  • Participate in cross-functional diagnostic team meetings and meetings with the external diagnostic test providers to track and monitor deliverables.
  • Collaborate with GRA colleagues to document and comply with diagnostic product requirements globally.
  • Monitor current and pending approvals in specific therapeutic/companion diagnostic/medical device areas and be knowledgeable of laws, directives, guidance(s) and requirements related to those areas.
  • Provide assessments of the impacts of new and changing regulations on the company objectives to project and management teams.
  • Support GRA Diagnostics in becoming a first-in-class organization by working internally and externally (i.e., participating in working groups, consortia, and trade associations, such as AdvaMed) to shape regulatory framework, identify process improvements.

Requirements

  • A minimum of a Bachelor’s degree in Biochemistry, Microbiology, Pharmacy, Life Sciences or a health-related discipline is required.
  • Advanced degree (Master’s, PharmD, PhD) preferred.
  • A minimum of 10 years of experience in a decision-making role on a pharmaceutical therapeutic team is required.
  • A minimum 5 years of relevant diagnostics regulatory experience with U.S. submissions (Q-Sub, IDE, 510k, PMA) and EU CE Conformity Certification marking is required.
  • A minimum of 5 years of translational science experience working with diagnostic test providers is required.
  • Strong experience with regulatory submissions and communication with Health Authorities is required.
  • Strong understanding of medical device development is required.
  • Proficient understanding of in vitro diagnostic technologies is required.
  • Knowledge of the drug development process is preferred.
  • Knowledge of therapeutic product regulations is preferred.
  • Regulatory Affairs Certification (RAC) is preferred.
  • Experience successfully working within a cross-functional team environment as a contributor, decision maker, and creator of innovative regulatory strategies is required.
  • Must have excellent verbal and written communication skills.
  • Must have strong analytical and strategic thinking skills.
  • Must be flexible and innovative with the ability to work in a changing, complex, and ambiguous environment.
  • Must have the ability to work independently, managing daily activities and project deliverables with limited management oversight.
  • The ability to present complex information to cross-functional project teams and senior management in a clear and concise manner is required.
  • The ability to identify regulatory risks and mitigations is required.
  • The ability to collaborate with all levels across a matrix organization is required.

Benefits

  • Medical
  • Dental
  • Vision
  • Life insurance
  • Short- and long-term disability
  • Business accident insurance
  • Group legal insurance
  • Consolidated retirement plan (pension)
  • Savings plan (401(k))
  • Vacation - up to 120 hours per calendar year
  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
  • Holiday pay, including Floating Holidays - up to 13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year
  • Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
  • Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member
  • Caregiver Leave - 10 days
  • Volunteer Leave - 4 days
  • Military Spouse Time-Off - 80 hours

Job title

Associate Director, Global Regulatory Affairs – Diagnostics

Job type

Full Time

Experience level

Senior

Salary

$137,000 - $235,750 per year

Degree requirement

Bachelor's Degree

Location requirements

HybridRaritanUnited States

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