🚀 Associate Director, Global Regulatory Affairs Diagnostics

Associate Director, Global Regulatory Affairs Diagnostics

Johnson & Johnson – Innovative Medicine R&D – is recruiting an Associate Director for our global regulatory affairs diagnostics function. The role is a hybrid position located in Raritan, NJ or Spring House, PA, with remote work options considered on a case‑by‑case basis. This position reports to the Global Regulatory Affairs (GRA) organization and supports in‑vitro diagnostics (IVD) and medical device (MD) regulatory activities for J&J therapeutic product development.

Job Description

The Associate Director will develop and implement regulatory strategies for diagnostic products, coordinate global submissions, maintain external contacts with health authorities, and provide guidance to pharmaceutical teams on diagnostic regulations.

Principal Responsibilities

• Prepare, review, and implement regulatory strategies for diagnostic products related to therapeutic product development.
• Oversee global submissions for new IVD and MD products to health authorities.
• Maintain contacts and negotiate with U.S., EU, PMDA, and other authorities to obtain timely registration.
• Provide training to pharmaceutical project teams regarding in‑vitro diagnostic regulations and strategy.
• Draft and review U.S. and EU study risk determinations for investigational diagnostic products used in therapeutic clinical studies.
• Coordinate submission of investigational and new in‑vitro diagnostic medical device applications, including CDRH Q‑submissions, IDE, EU IVDR performance study applications, and marketing authorizations.
• Track and respond to RFIs from regulatory authorities and manage cross‑functional responses.
• Communicate with regulatory authorities to expedite approval of diagnostic submissions.
• Participate in global regulatory team meetings and provide updates on diagnostic deliverables and timelines.
• Collaborate with GRA colleagues to document and comply with diagnostic product requirements globally.
• Monitor regulatory landscape and assess impacts of new regulations on company objectives.
• Support GRA Diagnostics in regulatory framework development and process improvements through industry groups and consortia.

Qualifications

• Bachelor’s degree in Biochemistry, Microbiology, Pharmacy, Life Sciences, or related health discipline; advanced degree (Master’s/PharmD/PhD) preferred.
• Minimum 10 years of decision‑making experience on a pharmaceutical therapeutic team.
• Minimum 5 years of diagnostics regulatory experience with U.S. submissions (Q‑Sub, IDE, 510(k), PMA) and EU CE conformity marking.
• Minimum 5 years of translational science experience working with diagnostic test providers.
• Strong experience with regulatory submissions and communication with health authorities.
• Solid understanding of medical device development and in‑vitro diagnostic technologies.
• Knowledge of drug development process and therapeutic product regulations preferred.
• Regulatory Affairs Certification (RAC) preferred.
• Excellent verbal, written, analytical and strategic thinking skills.
• Ability to work independently, manage daily activities with limited oversight, and present complex information to cross‑functional teams.
• Strong collaboration skills across matrix organizations.

Compensation

Base salary range (U.S.): $137,000 – $235,750.

Benefits

• Paid time off: vacation up to 120 hours/year, sick time up to 40 hours/year (56 hours/year for Washington residents), holiday pay up to 13 days/year, work‑personal‑family time up to 40 hours/year.
• Medical, dental, vision, life insurance, short‑ and long‑term disability, accident insurance, legal insurance.
• 401(k) retirement plan with company match.
• Long‑term incentive plan eligibility.

Application Deadline

This posting will close on November 11, 2025 (may be extended).

Equal Opportunity

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.

Accommodations for Applicants with Disabilities

Contact the Employee Health Support Center at ra‑ for accommodation requests.

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