Associate Director, Global Regulatory Affairs Diagnostics

Role Summary

Associate Director, Global Regulatory Affairs Diagnostics. The role supports in vitro diagnostics regulatory affairs, including companion diagnostics, in support of Johnson & Johnson therapeutic product development. Hybrid role located in Raritan, NJ or Spring House, PA; remote options may be considered on a case-by-case basis.

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 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 educational training to pharmaceutical project teams regarding in vitro diagnostic regulations and regulatory strategy.
• Draft and/or review US 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 with diagnostic test providers (including Q-submissions, IDEs, CE/IVDR, and related submissions).
• Track RFIs from regulatory authorities and manage cross-functional responses.
• Communicate with regulatory authorities and notified bodies to expedite regulatory submissions.
• Participate in Global Regulatory Team meetings and provide updates on diagnostic deliverables and timelines; engage in cross-functional diagnostic team meetings and external provider meetings.
• 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 on applicable laws and guidance.
• Assess impacts of new and changing regulations on company objectives and communicate to project/management teams.
• Support GRA Diagnostics in shaping regulatory framework through internal and external collaboration with groups such as AdvaMed.

Qualifications

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

Skills

• Regulatory strategy and submissions for IVD/MD products
• Regulatory authority liaison and conflict resolution
• Cross-functional collaboration and project management
• Regulatory risk assessment and mitigation
• In vitro diagnostic technologies and medical device understanding