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. Learn more at https://www.jnj.com

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Regulatory Science

Job Category:

Scientific/Technology

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

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 (U.S., EU, PMDA, and others) 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.  This includes, but is not limited to, submission of CDRH Q-submissions (study risk determination requests and pre-submission meeting requests), CDRH Investigational Device Exemptions, EU IVDR Performance Study Applications, and diagnostic product marketing authorization submissions.

• 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, gui