Associate Director, Global Regulatory Affairs Diagnostics

Role Summary

Associate Director, Global Regulatory Affairs Diagnostics at Johnson & Johnson Innovative Medicine R&D, supporting in vitro diagnostics regulatory affairs including companion diagnostics in therapeutic product development. Hybrid role based in Raritan, NJ or Spring House, PA with potential remote options on a case-by-case basis. Reports to the GRA organization within Innovative Medicine.

Responsibilities

• Contribute to the development and realization of business objectives by preparing, reviewing, and implementing regulatory strategies for diagnostic products related to therapeutic product development.
• Oversee the coordination and compilation of global submissions for In Vitro Diagnostics (IVD) and Medical Devices (MD) to Health Authorities.
• Maintain external contacts and negotiate with Health Authorities 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 clinical studies.
• Coordinate and submit investigational and new in vitro diagnostic medical device applications to regulatory authorities (e.g., CDRH submissions, EU IVDR, and marketing authorizations).
• Track RFIs from regulatory authorities and manage cross-functional responses.
• Communicate with regulatory authorities and notified bodies to expedite approval of diagnostic submissions.
• Participate in Global Regulatory Team meetings and provide updates on diagnostic deliverables and timelines.
• Participate in cross-functional diagnostic team meetings and external provider meetings to monitor deliverables.
• Collaborate with GRA colleagues to document and comply with global diagnostic product requirements.
• Monitor current and pending approvals in therapeutic/companion diagnostic/medical device areas and stay informed on applicable laws and guidance.
• Assess impacts of regulatory changes on company objectives and communicate to project/management teams.
• Support GRA Diagnostics in shaping regulatory framework and process improvements through internal and external collaboration.

Qualifications

• Bachelor’s degree in Biochemistry, Microbiology, Pharmacy, Life Sciences or health-related field required; advanced degree preferred.
• Minimum 10 years in a decision-making role on a pharmaceutical therapeutic team.
• Minimum 5 years of relevant diagnostics regulatory experience with U.S. submissions (Q-Sub, IDE, 510(k), PMA) and EU CE marking.
• Minimum 5 years of translational science experience working with diagnostic test providers.
• Strong experience with regulatory submissions and communications with Health Authorities.
• Strong understanding of medical device development and in vitro diagnostic technologies.
• Knowledge of the drug development process and therapeutic product regulations preferred.
• Regulatory Affairs Certification (RAC) preferred.
• Experience working in a cross-functional team, contributing to innovative regulatory strategies.
• Excellent verbal and written communication, strong analytical and strategic thinking skills.
• Ability to work independently in a changing, complex environment and present complex information clearly to cross-functional teams and senior management.
• Ability to identify regulatory risks and mitigations and collaborate across a matrix organization.