Johnson & Johnson is recruiting for an Associate Director Global Regulatory Affairs Diagnostics to be located in Titusville, NJ; Raritan, NJ; Spring House PA; La Jolla, CA; or SF Bay Area, CA. This position can be full-time in the office or hybrid (3 days in the office/2 days remote).
At Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Johnson & Johnson discovers and develops innovative medical solutions to address important unmet medical needs in the following therapeutic areas: immunology, oncology, neuroscience, infectious diseases & vaccines, cardiovascular & metabolism, and pulmonary hypertension. Please visit http://www.JanssenRnD.com for more information.
We are Johnson & Johnson. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. We are guided by our Credo.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Johnson & Johnson provides an opportunity to work in a highly innovative and growing precision medicine business. This position reports into the Johnson & Johnson Innovative Medicine (pharmaceutical sector) Global Regulatory Affairs (GRA) organization. The function supports in vitro diagnostics regulatory affairs, including companion diagnostics, in support of Johnson & Johnson therapeutic product development.
Responsibilities & Accountabilities
- Support the Global Regulatory Affairs Diagnostic leader in managing and executing all diagnostics-related regulatory deliverables in support of Johnson & Johnson therapeutic product development.
- Prepare, review, and implement regulatory strategies and plans for diagnostic products related to therapeutic product development.
- Provide guidance, support, and training to pharmaceutical project teams regarding in vitro diagnostic regulations and regulatory strategy.
- Draft the US 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 with an emphasis on North America and the European Union. 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 all 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 regulatory submissions.
- Participate in therapeutic product Global Regulatory Team 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. Assist in managing the GRA Diagnostics team’s deliverables and the partner’s regulatory deliverables.
- Collaborate with global Global Regulatory Affairs colleagues to document and comply with diagnostic product requirements globally.
- Keep international colleagues informed of therapeutic product development activities via the Global Regulatory Team (GRT) diagnostic meetings and project tracking applications.
- Monitor the environment for laws, directives, and regulations related to in vitro diagnostics.
- Support the Global Regulatory Affairs Diagnostics in becoming a first-in-class organization by participating on initiatives related to: project management, training, regulatory intelligence, communication practices, or process improvement.
- Bachelors, preferably Masters, degree in biochemistry, microbiology, pharmacy or life-science or health-related field with minimum 10 years business experience.
- Strong understanding of analytical and clinical validation of in vitro diagnostic tests.
- Minimum 5 years relevant regulatory experience in US submissions (Q-Sub, IDE, 510k, PMA) and EU CE marking OR 5-10 years of translational science experience working with diagnostic test providers.
- Track record of successfully working within a cross-functional team environment as a contributor, decision maker, and creator of innovative regulatory strategy.
Proficient understanding of in vitro diagnostic technologies.
- Knowledge of the drug development process and therapeutic product regulations.
- RAC Certification.
- Collaborative team-player with a dynamic personality.
- Excellent verbal and written communication skills. Ability to present complex information to cross-functional project teams and senior management in a clear and concise manner.
- Strategic thinker who can also focus on the details.
- Independent: manages daily activities and project deliverables with limited management oversight.
- Excellent analytical and critical thinking skills required. Ability to identify regulatory risks and mitigations.
- Flexible & innovative: comfortable working in a changing, complex, and ambiguous environment
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
The anticipated base pay range for this position in the San Francisco Bay Area, CA is $166,00 to $267,145.
The anticipated base pay range for this position in all other US locations is $135,000 - $232,300.
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 corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s 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 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
Additional information can be found through the link below.
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits