Johnson & Johnson
Associate Director, Global Regulatory Affairs Diagnostics
Johnson & Johnson, Raritan, New Jersey, us, 08869
Associate Director, Global Regulatory Affairs Diagnostics
Johnson & Johnson is seeking an Associate Director for Global Regulatory Affairs Diagnostics within our Innovative Medicine R&D portfolio. This hybrid role can be located in Raritan, NJ or Spring House, PA, and remote work may be considered on a case‑by‑case basis.
The successful candidate will provide regulatory leadership for in‑vitro diagnostics (IVD) and medical devices (MD) that support our therapeutic product development. This includes preparing global submissions, liaising with health authorities, managing regulatory strategy, and providing guidance to cross‑functional teams.
Principal Responsibilities
Contribute to the development and realization of business objectives by preparing, reviewing, and implementing regulatory strategies for diagnostic products related to therapeutic product development.
Oversee the coordination and compilation of global submissions for new IVD and MD products to health authorities.
Maintain appropriate external contacts and negotiate with health authorities (U.S., EU, PMDA, and others) to obtain timely registration of diagnostic products.
Provide guidance, support, and educational training to pharmaceutical project teams regarding in‑vitro diagnostic regulations and strategy.
Draft and/or review U.S. and EU Study Risk Determinations for investigational diagnostic products used in therapeutic clinical studies.
Handle timely coordination, compilation, and submission of investigational and new IVD medical device applications, including CDRH Q‑submissions, CDRH Investigational Device Exemptions, EU IVDR Performance Study Applications, and diagnostic product marketing authorization submissions.
Track Requests for Information (RFI) from regulatory authorities related to diagnostic product submissions and manage cross‑functional responses.
Communicate with regulatory authorities and notified bodies to expedite approval of diagnostic regulatory submissions.
Participate in the Global Regulatory Team meetings and provide updates on diagnostic product deliverables and timelines.
Collaborate with diagnostic team meetings and meetings with 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 keep up to date with applicable laws, directives, guidance, and requirements.
Provide assessments of the impacts of new and changing regulations on company objectives to project and management teams.
Support GRA Diagnostics in becoming a first‑in‑class organization by participating in working groups, consortia, and trade associations to shape regulatory framework and identify process improvements.
Qualifications
Minimum Bachelor’s degree in Biochemistry, Microbiology, Pharmacy, Life Sciences, or a related health‑related discipline; advanced degree (Master’s, PharmD, PhD) preferred.
At least 10 years of experience in a decision‑making role on a pharmaceutical therapeutic team.
At least 5 years of relevant diagnostics regulatory experience with U.S. submissions (Q‑Sub, IDE, 510k, PMA) and EU CE conformity certification marking.
At least 5 years of translational science experience working with diagnostic test providers.
Strong experience with regulatory submissions and communication with health authorities.
Strong understanding of medical device development and in‑vitro diagnostic technologies.
Knowledge of the drug development process and therapeutic product regulations preferred.
Regulatory Affairs Certification (RAC) preferred.
Excellent verbal and written communication skills.
Strong analytical and strategic thinking skills.
Ability to work independently, manage daily activities and project deliverables with limited oversight.
Ability to present complex information to cross‑functional teams and senior management clearly and concisely.
Ability to identify regulatory risks and mitigations.
Ability to collaborate across a matrix organization.
Compensation and Benefits The anticipated base pay range for U.S. locations is $137,000 to $235,750. This position is eligible for an annual performance bonus and a long‑term incentive program. Standard benefits include medical, dental, vision, life insurance, short‑ and long‑term disability, and a 401(k) retirement plan.
Time Off and Other Benefits
Vacation – up to 120 hours per calendar year
Sick time – up to 40 hours per calendar year (56 hours for employees residing in Washington)
Holiday pay, including floating holidays – up to 13 days per calendar year
Work, personal, and family time – up to 40 hours per calendar year
Equal Opportunity Employer 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.
Application Deadline This job posting is anticipated to close on November 11, 2025.
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The successful candidate will provide regulatory leadership for in‑vitro diagnostics (IVD) and medical devices (MD) that support our therapeutic product development. This includes preparing global submissions, liaising with health authorities, managing regulatory strategy, and providing guidance to cross‑functional teams.
Principal Responsibilities
Contribute to the development and realization of business objectives by preparing, reviewing, and implementing regulatory strategies for diagnostic products related to therapeutic product development.
Oversee the coordination and compilation of global submissions for new IVD and MD products to health authorities.
Maintain appropriate external contacts and negotiate with health authorities (U.S., EU, PMDA, and others) to obtain timely registration of diagnostic products.
Provide guidance, support, and educational training to pharmaceutical project teams regarding in‑vitro diagnostic regulations and strategy.
Draft and/or review U.S. and EU Study Risk Determinations for investigational diagnostic products used in therapeutic clinical studies.
Handle timely coordination, compilation, and submission of investigational and new IVD medical device applications, including CDRH Q‑submissions, CDRH Investigational Device Exemptions, EU IVDR Performance Study Applications, and diagnostic product marketing authorization submissions.
Track Requests for Information (RFI) from regulatory authorities related to diagnostic product submissions and manage cross‑functional responses.
Communicate with regulatory authorities and notified bodies to expedite approval of diagnostic regulatory submissions.
Participate in the Global Regulatory Team meetings and provide updates on diagnostic product deliverables and timelines.
Collaborate with diagnostic team meetings and meetings with 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 keep up to date with applicable laws, directives, guidance, and requirements.
Provide assessments of the impacts of new and changing regulations on company objectives to project and management teams.
Support GRA Diagnostics in becoming a first‑in‑class organization by participating in working groups, consortia, and trade associations to shape regulatory framework and identify process improvements.
Qualifications
Minimum Bachelor’s degree in Biochemistry, Microbiology, Pharmacy, Life Sciences, or a related health‑related discipline; advanced degree (Master’s, PharmD, PhD) preferred.
At least 10 years of experience in a decision‑making role on a pharmaceutical therapeutic team.
At least 5 years of relevant diagnostics regulatory experience with U.S. submissions (Q‑Sub, IDE, 510k, PMA) and EU CE conformity certification marking.
At least 5 years of translational science experience working with diagnostic test providers.
Strong experience with regulatory submissions and communication with health authorities.
Strong understanding of medical device development and in‑vitro diagnostic technologies.
Knowledge of the drug development process and therapeutic product regulations preferred.
Regulatory Affairs Certification (RAC) preferred.
Excellent verbal and written communication skills.
Strong analytical and strategic thinking skills.
Ability to work independently, manage daily activities and project deliverables with limited oversight.
Ability to present complex information to cross‑functional teams and senior management clearly and concisely.
Ability to identify regulatory risks and mitigations.
Ability to collaborate across a matrix organization.
Compensation and Benefits The anticipated base pay range for U.S. locations is $137,000 to $235,750. This position is eligible for an annual performance bonus and a long‑term incentive program. Standard benefits include medical, dental, vision, life insurance, short‑ and long‑term disability, and a 401(k) retirement plan.
Time Off and Other Benefits
Vacation – up to 120 hours per calendar year
Sick time – up to 40 hours per calendar year (56 hours for employees residing in Washington)
Holiday pay, including floating holidays – up to 13 days per calendar year
Work, personal, and family time – up to 40 hours per calendar year
Equal Opportunity Employer 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.
Application Deadline This job posting is anticipated to close on November 11, 2025.
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