Hybrid Associate Director, Global Regulatory Affairs – Diagnostics

at OneTrust

• 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: Hybrid, Raritan, United States

About the role

• Associate Director for Global Regulatory Affairs in diagnostics at Johnson & Johnson. Supporting in vitro diagnostics regulatory strategy and submissions for therapeutic product development.

Responsibilities

• 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