Associate Director, Global Regulatory Affairs Diagnostics

Role Summary

Associate Director, Global Regulatory Affairs Diagnostics. Hybrid role in Raritan, NJ or Spring House, PA, supporting in vitro diagnostics regulatory affairs including companion diagnostics in support of Johnson & Johnson 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 external contacts and negotiate with HAs (U.S., EU, PMDA, and others) to obtain timely registration of diagnostic products.
• Provide guidance, support, and training to pharmaceutical project teams regarding in vitro diagnostic regulations and regulatory strategy.
• Draft and/or review U.S. and EU Study Risk Determinations for investigational diagnostic products used in therapeutic product clinical studies.
• Coordinate and submit investigational and new in vitro diagnostic medical device applications to regulatory authorities (e.g., CDRH Q-submissions, IDEs, EU IVDR, and marketing authorization submissions).
• Track RFIs from regulatory authorities and manage cross-functional responses.
• Communicate with regulatory authorities and notified bodies to expedite approvals.
• Participate in Global Regulatory Team (GRT) meetings and update teams on diagnostic deliverables and timelines.
• Participate in cross-functional diagnostic team meetings and with external diagnostic test providers to monitor deliverables.
• Collaborate with GRA colleagues to document and comply with diagnostic product requirements globally.
• Monitor approvals in therapeutic/companion diagnostic/medical device areas and stay informed on applicable laws, directives, guidance, and requirements.
• Provide assessments of regulatory impacts on company objectives to project and management teams.
• Support GRA Diagnostics in shaping regulatory framework and process improvements through internal/external collaboration.

Qualifications

• 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 of 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 working within a cross-functional team environment as a contributor, decision maker, and creator of regulatory strategies is required.
• Excellent verbal and written communication skills.
• Strong analytical and strategic thinking skills.
• Flexibility and innovation to work in a changing, complex, and ambiguous environment.
• Ability to work independently, managing daily activities and project deliverables with limited management oversight.
• Ability to present complex information to cross-functional project teams and senior management clearly and concisely.
• Ability to identify regulatory risks and mitigations.
• Ability to collaborate with all levels across a matrix organization.

Education

• Bachelor’s degree required; advanced degree preferred.