Associate Director, Global Regulatory Affairs Diagnostics

Johnson & Johnson • Raritan, NJ

47d • $137,000 - $235,750 • Hybrid

About The Position

At Johnson & Johnson,â we believe health is everything. Our strength in healthcare innovation empowers us to build aâ world where complex diseases are prevented, treated, and cured,â where treatments are smarter and less invasive, andâ solutions are personal.â 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.â Learn more at https://www.jnj.com 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.

Requirements

• A minimum of a Bachelor's degree in Biochemistry, Microbiology, Pharmacy, Life Sciences or a health-related discipline is required.
• 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
• 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.

Nice To Haves

• Advanced degree (Master's, PharmD, PhD) preferred.
• Knowledge of the drug development process is preferred.
• Knowledge of therapeutic product regulations is preferred.
• Regulatory Affairs Certification (RAC) is preferred.

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.

Benefits

• 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: 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Industry: Chemical Manufacturing
• Number of Employees: 5,001-10,000 employees