Associate Director, Global Regulatory Affairs Diagnostics

Job Title : Associate Director, Global Regulatory Affairs Diagnostics

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, Global Regulatory Affairs Diagnostics. This position is a hybrid role and can be located in Raritan, NJ or Spring House, PA. Remote work options may be considered on a case-by-case basis and if approved by the Company. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

The Associate Director, Global Regulatory Affairs Diagnostics will provide an opportunity to work in a highly innovative and growing precision medicine business. This position will report into the Johnson & Johnson Innovative Medicine (pharmaceutical sector) Global Regulatory Affairs (GRA) organization and will support in vitro diagnostics Regulatory Affairs, including companion diagnostics, in support of Johnson & Johnson therapeutic product development.

Principal 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 appropriate external contacts and negotiate with HAs to obtain timely registration of the 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 the investigational diagnostic products used in the therapeutic product clinical studies.
• In partnership with the diagnostic test provider, handle the timely coordination, compilation, and submission of investigational and new in vitro diagnostic medical device applications to the regulatory authorities.
• Track Requests for Information (RFI) received from regulatory authorities related to diagnostic product submissions and manage the cross-functional responses to the RFI.
• 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 to the teams regarding diagnostic product deliverables and timelines.
• Participate in cross-functional diagnostic team meetings and meetings with the external diagnostic test providers to track and monitor deliverables.
• Collaborate with GRA colleagues to document and comply with diagnostic product requirements globally.
• Monitor current and pending approvals in specific therapeutic / companion diagnostic / medical device areas and be knowledgeable of laws, directives, guidance(s) and requirements related to those areas.
• Provide assessments of the impacts of new and changing regulations on the company objectives to project and management teams.
• Support GRA Diagnostics in becoming a first-in-class organization by working internally and externally to shape regulatory framework, identify process improvements.

Qualifications :

The anticipated base pay range for U.S. locations is $137,000 to $235,750. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar / performance year. Bonuses are awarded at the Company's discretion on an individual basis.

Employees and / or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs : medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits :

For additional general information on company benefits, please go to : https : / / www.careers.jnj.com / employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

This job posting is anticipated to close on November 11, 2025. The Company may however extend this time-period, in which case the posting will remain available on https : / / www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource.