Associate Director, Global Regulatory Affairs Diagnostics

Role Summary

Associate Director, Global Regulatory Affairs Diagnostics. Hybrid role located in Raritan, NJ or Spring House, PA, supporting in vitro diagnostics regulatory affairs including companion diagnostics in Johnson & Johnson’s Innovative Medicine R&D. Remote options may be considered case-by-case.

Responsibilities

• Contribute to regulatory strategies for diagnostic products related to therapeutic development.
• Coordinate and compile global submissions for In Vitro Diagnostics and Medical Devices to Health Authorities.
• Maintain external contacts and negotiate with Health Authorities to obtain timely registration.
• Provide guidance and training to project teams on in vitro diagnostic regulations and regulatory strategy.
• Draft/review U.S. and EU study risk determinations for investigational diagnostic products.
• Coordinate and submit regulatory applications with diagnostic test providers (e.g., CDRH submissions, EU IVDR, and marketing authorization submissions).
• Track RFIs from regulatory authorities and manage cross-functional responses.
• Expedite regulatory submissions through communication with authorities and notified bodies.
• Participate in Global Regulatory Team meetings and update teams on deliverables and timelines.
• Collaborate with cross-functional diagnostic teams and external providers to track deliverables.
• Document and comply with diagnostic product requirements globally with GRA colleagues.
• Monitor regulatory approvals and remain knowledgeable of relevant laws and directives.
• Assess regulatory impacts of new regulations on project objectives and communicate to management.
• Support GRA Diagnostics through external collaboration to shape regulatory framework and drive process improvements.

Qualifications

• Bachelor‚Äôs degree in Biochemistry, Microbiology, Pharmacy, Life Sciences or related field; Advanced degree preferred.
• 10+ years in a decision-making role on a pharmaceutical therapeutic team.
• 5+ years of diagnostics regulatory experience with U.S. submissions (Q-Sub, IDE, 510k, PMA) and EU CE marking.
• 5+ years translational science experience with diagnostic test providers.
• Strong experience with regulatory submissions and Health Authority communication.
• Strong understanding of medical device development and in vitro diagnostic technologies.
• RAC preferred; knowledge of drug development and therapeutic product regulations preferred.
• Experience in cross-functional teams, with excellent verbal and written communication skills.
• Strong analytical and strategic thinking; ability to work independently in a dynamic environment.
• Ability to present complex information clearly to cross-functional teams and senior management; identify regulatory risks and mitigations.

Skills

• Regulatory strategy development
• Global regulatory submissions (IVD, MD)
• Regulatory authorities liaison
• Cross-functional team collaboration
• Regulatory risk assessment
• In vitro diagnostic technologies
• Medical device development

Education

• Bachelor‚Äôs degree in Biochemistry, Microbiology, Pharmacy, Life Sciences or related field; advanced degree preferred.