Manager, Regulatory Affairs North America

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

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Raritan, New Jersey, 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 https://www.jnj.com/innovative-medicine

We are searching for the best talent for Manager, Regulatory Affairs North America. This is a hybrid position (3 days in office and 2 days remote) and will be located in Raritan, NJ.

Purpose:
The Manager, Regulatory Affairs North America, acts as a specialist on the global regulatory sub team and cross-functional project teams in the development of regulatory strategy and submission plans to ensure timely commercialization of new and modified products into North American markets

You will be responsible for:

• Conduct regulatory research to gather pertinent histories, precedents, and other information crucial for product advancement in the US.
• Record and convey details and outcomes of FDA interactions to the GRT and applicable senior management.
• Ensure regulatory compliance for products, including DSURs, Post-Market Commitments (PMCs), pediatric requirements, and other agency obligations.
• Under supervision, interact with Health Authorities (HA) regarding program-specific issues and serve as secondary HA point-of-contact
• Assist in the preparation of HA interactions and coordinate team readiness for interactions, including strategic planning and developing regulatory risks and mitigation scenarios
• Support/lead coordination of responses to Regulatory Agency queries in collaboration with the cross-functional team, consistent with the regulatory strategy
• Consult on compliance with regulations by providing in depth knowledge to enable products that are developed, manufactured, or distributed to meet required regulatory agency regulations
• Participate in global and regional regulatory team meetings and advise the regulatory team on applicable regulatory requirements, project-specific regulatory issues, regulatory guidance on US regulatory mechanisms to optimize product development (e.g. orphan drug, fast track, early access, pediatric plan) and submission strategies
• Maintain an in-depth understanding of the regional regulatory environment and competitive intelligence within assigned programs and therapeutic portfolio
• Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support, and product complaints
• Review clinical trial plans, protocols and submission plans, ensuring alignment with regulatory requirements
• Provide guidance for teams on product labeling, claims support, promotional and scientific materials, and other related activities to ensure all regulatory requirements are met throughout the development process
• Influence others within area of immediate responsibility, scope and level to accept new insights, practices and approaches
• Proactively anticipate issues; exercise judgment in developing new approaches/solutions and resolving issues
• Coaches and trains junior colleagues in techniques, processes, and responsibilities
• Integrates Johnson & Johnson's Credo and Leadership Imperatives into team goals and decision making.

Qualifications / Requirements:
Education:
One of the following combinations of education and experience is required:

• A Bachelor's Degree with a minimum of 6 years of relevant experience
• An Advanced/Master's Degree/PharmD with a minimum of 4 years of relevant experience
• A PhD with a minimum 2 years of relevant experience

Required:

• Skilled at optimally prioritizing assignments for multiple projects simultaneously is required
• Experience within a cross-functional team environment as an individual contributor and decision maker within a matrix organization is required
• Strong interpersonal and communication skills is required
• Previous health regulatory industry experience and understanding of the drug or device development process is required
• Relevant regulatory affairs experience in pharmaceutical/biotech is required

Preferred:

• Understanding of regulatory submission and approval process (eg, IND/CTA, and/or NDA/MAA fillings) and applicable US regulatory guidelines is strongly preferred. Experience responding to Healthy Authority (HA) requests, managing HA interactions and management of applications is strongly preferred.
• Project management experience is preferred
• Diverse therapeutic area experience is preferred
• Cardiovascular Drug Development experience is preferred

The anticipated base pay range for this position in all other U.S. locations is $115,000 to $197,800.
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

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

This job posting is anticipated to close on May 2nd, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com 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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.