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, Spring House, Pennsylvania, 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 Lead Regulatory Scientist, Global Regulatory Affairs (Oncology) to 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.

Purpose: This position will support the North American Regulatory Leader (NARL) and/or Global Regulatory Leader (GRL) for regulatory activities for compounds in development and/or marketed products in the assigned portfolio within the Oncology therapeutic area.

You will be responsible for:

• Provide support to the North American Regulatory Leader (NARL) and/or Global Regulatory Leader (GRL) for regulatory activities for products in the assigned portfolio, including assuring that content and intent of regulatory filings support the global regulatory strategy
• Participate in global regulatory team meetings as appropriate
• Advise the regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
• Develop an understanding of the North American regulatory environment, competitor intelligence and therapeutic area
• Act as back-up for contact with Regulatory Agencies as needed
• Draft documentation for Regulatory Agency communication
• Assist in the preparation of meetings with Regulatory Agencies
• Collaborate with Local Operating Companies (LOCs), and ensure responses to queries are made in a timely manner, and that content is consistent with the regulatory strategy
• Assist in the development and improvement of processes related to regulatory submissions
• Review clinical trial plans and protocols and ensure alignment with regulatory requirements
• Provide regulatory support throughout registration process and life-cycle management
• Advise team regarding required documents and submission strategies (in collaboration with LOCs as appropriate)
• Assist with timely availability of submission documents and ensure that all document components are in place on time
• Draft and review some document content (depending on level of regulatory knowledge/expertise)
• Prepare, hold and lead cross-functional team meetings as appropriate
• Understand submission details and collaborate closely with Submission Management
• Review and approve submission plans
• Review of submission documents to ensure compliance with regulatory requirements
• Assist with submission and acceptance of the submission package
• Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans
• Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints
• Serve as the Regulatory representative on specific multi-discipline teams
• Stay on top of current and pending approvals in specific therapeutic areas and knowledgeable of laws, guidances and requirements related to those areas.

Qualifications / Requirements:

Education:

• Minimum of a Bachelor's degree is required.

Skills/Experience:

Required:

• Minimum of 6 years of previous health regulated industry experience or relevant academic experience
• Understanding of the drug development process
• Basic understanding of the regulatory submission and approval process
• Knowledge of US guidelines and practices in the regulatory environment
• Must be able to work optimally within a diverse team environment and as an individual contributor
• Project management, oral & written communication skills, organization and multi-tasking skills
• Teamwork skills, including effective communication and conflict resolution skills.
• Exercises strong organizational and time management skills
• Demonstrated ability of critical thinking and contingency planning with respect corporate objectives.
• Effective critical thinking including problem solving and goal setting for improved efficiencies.

Preferred:

• Direct experience in regulatory affairs is desirable
• Oncology Drug Development experience
• Regulatory, Clinical or R& D experience with products in early and late development stages
• Experience responding to FDA requests, handling FDA interactions, and lifecycle management of IND/NDA/BLA applications

Other:

• This position may require less than 10% travel.

The expected pay range for this position is $105, 000 to $169, 050

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

The compensation and benefits information set forth in this posting applies to candidates hired in the United States.

Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

This job posting is anticipated to close on June 21, 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.

#LI-Hybrid

The anticipated base pay range for this position is:

$105, 000-$169, 050

Additional Description for Pay Transparency:

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)). This position is eligible to participate in the Company’s long-term incentive program. 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 of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http: //www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.