Associate Director, Global Regulatory Affairs Diagnostics

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 & 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 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 (i.e. participating in working groups consortia and trade associations such as AdvaMed) to shape regulatory framework identify process improvements.

Qualifications:

• A minimum of a Bachelors degree in Biochemistry Microbiology Pharmacy Life Sciences or a health-related discipline is required. Advanced degree (Masters PharmD PhD) preferred.

• A minimum of 10 years of experience in a decision-making role on a pharmaceutical therapeutic team is required.

• A minimum 5 years of relevant diagnostics regulatory experience with U.S. submissions (Q-Sub IDE 510k PMA) and EU CE Conformity Certification marking is required.

• A minimum of 5 years of translational science experience working with diagnostic test providers is required.

• Strong experience with regulatory submissions and communication with Health Authorities is required.

• Strong understanding of medical device development is required

• Proficient understanding of in vitro diagnostic technologies is required

• Knowledge of the drug development process is preferred.

• Knowledge of therapeutic product regulations is preferred.

• Regulatory Affairs Certification (RAC) is preferred.

• Experience successfully working within a cross-functional team environment as a contributor decision maker and creator of innovative regulatory strategies is required.

• Must have excellent verbal and written communication skills.

• Must have strong analytical and strategic thinking skills.

• Must be flexible and innovative with the ability to work in a changing complex and ambiguous environment.

• Must have the ability to work independently managing daily activities and project deliverables with limited management oversight.

• The ability to present complex information to cross-functional project teams and senior management in a clear and concise manner is required.

• The ability to identify regulatory risks and mitigations is required.

• The ability to collaborate with all levels across a matrix organization is required.

The anticipated base pay range for U.S. locations is $137000 to $235750.

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 corporations performance over a calendar/ performance year. Bonuses are awarded at the Companys 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 Companys consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

• Holiday pay including Floating Holidays - up to 13 days per calendar year

• Work Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits please go to: 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 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.

#LI-Hybrid

Required Skills:

Preferred Skills:

Consulting Corporate Governance Drug Discovery Development Fact-Based Decision Making Healthcare Trends Interpersonal Influence Mentorship Public Policies Regulatory Compliance Regulatory Development Regulatory Environment Scientific Research Strategic Thinking Subject Matter Experts (SME) Collaboration Tactical Planning Technical Credibility Technical Writing

The anticipated base pay range for this position is :

The anticipated base pay range for U.S. locations is $137000 to $235750.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees and/or eligible dependents are 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. Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys long-term incentive program. Subject to the terms of their respective policies and date of hire Employees are eligible for the following time off benefits: Vacation 120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year Holiday pay including Floating Holidays 13 days per calendar year Work Personal and Family Time - up to 40 hours per calendar year Parental Leave 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours Additional information can be found through the link below. Experience:

Director