Associate Director, Global Regulatory Affairs Diagnostics

Role Summary

Associate Director, Global Regulatory Affairs Diagnostics. Hybrid role in Raritan, NJ or Spring House, PA; remote options may be considered on a case-by-case basis. Supports 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 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 investigational diagnostic products used in therapeutic product clinical studies.
• Coordinate and submit investigational and new in vitro diagnostic medical device applications to regulatory authorities, including CDRH submissions, IDEs, EU IVDR Applications, and marketing authorization submissions.
• Track RFIs from regulatory authorities and manage cross-functional responses.
• 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 on diagnostic deliverables and timelines.
• Attend cross-functional diagnostic team meetings and meetings with external diagnostic test providers to track deliverables.
• Collaborate with GRA colleagues to document and comply with diagnostic product requirements globally.
• Monitor current and pending approvals in therapeutic/companion diagnostic/medical device areas and stay informed of applicable laws and guidance.
• Provide assessments of regulatory impacts on company objectives to project and management teams.
• Support GRA Diagnostics in shaping regulatory framework and process improvements through external engagements and working groups.

Qualifications

• Bachelor’s degree in Biochemistry, Microbiology, Pharmacy, Life Sciences or health-related discipline; advanced degree (Master’s, PharmD, PhD) preferred.
• Minimum 10 years of experience 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, 510k, PMA) and EU CE marking.
• Minimum 5 years of translational science experience with diagnostic test providers.
• Strong experience with regulatory submissions and communication with Health Authorities.
• Strong understanding of medical device development and in vitro diagnostic technologies.
• Knowledge of drug development and therapeutic product regulations preferred; RAC preferred.
• Experience working in a cross-functional team with innovative regulatory strategies.
• Excellent verbal and written communication; strong analytical and strategic thinking; ability to work independently in a changing environment.
• Ability to present complex information to cross-functional teams and senior management; identify regulatory risks and mitigations; collaborate across a matrix organization.

Skills

• Regulatory strategy development
• Global regulatory submissions (IVD, MD)
• Health Authority liaison
• Cross-functional collaboration
• Regulatory risk assessment
• Project management

Education

• As listed in qualifications above