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:

Atlanta, Georgia, United States, Raleigh, North Carolina, United States, 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 an Experienced RA Professional, Global TA (2 positions).

This is a remote role based in the United States. 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.

Remote work options may be considered on a case-by-case basis and if approved by the Company.
 

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

 

Purpose:
As an Experienced RA Professional, you will support drug development programs as well as marketed products across multiple therapeutic areas across J&J Innovative Medicine. You will gain broad and diverse regulatory experience supporting compounds in early to late drug development as well as life-cycle activities for approved products in J&J Innovative Medicine's portfolio via a flexible rotational model geared towards addressing business needs and individual career-development goals. Additionally, you will have the opportunity to develop leadership skills in individual/small group trainings and coaching experiences and participate in GRA organizational initiatives. Furthermore, you will acquire the business savvy to be successful in a complex, fast-paced, and innovative regulatory environment.

You will be responsible for:

• Participate in global regulatory team meetings and advise the regulatory team on applicable regulatory requirements, project-specific regulatory issues as assigned.
• Develop an understanding of the regulatory environment, competitor intelligence, and therapeutic area.
• Assist in the preparation of meetings and act as backup for contact with Regulatory Agencies as needed
• Ensure responses to Regulatory Agency queries are made in a timely manner, and that content is consistent with the regulatory strategy
• Draft and review some document content (depending on level of regulatory knowledge/ expertise)
• Review clinical trial plans, protocols and submission plans ensuring alignment with regulatory requirements
• Provide regulatory support throughout the registration process and life-cycle management
• Collaborate with team on required documents and submission strategies in preparation of submissions as assigned
• Stay on top of current and pending approvals in assigned therapeutic areas and is knowledgeable of laws, guidance’s, and requirements related to those areas.
• Proactively anticipates issues; exercises judgment in developing new approaches/solutions and resolving issues
• Influences or persuades others within area of immediate responsibility, scope and level to accept new ideas, practices and approaches
• Work cross-functionally, interacting with internal and external colleagues with coordination between departments
• Skilled at project managing and effectively prioritizing assignments for multiple projects simultaneously
• Strong interpersonal and communication skills
• May represent J&J or company externally with some degree of supervision
   

Qualifications / Requirements:

Education:

• Minimum of a Bachelor’s degree in a scientific or equivalent discipline is required

Required:

• Minimum of 2 years relevant industry experience and/or in an academic setting
• Basic understanding of the drug development process and drug product life cycle from discovery through marketing and post-approval requirements, with the capability to interpret and apply local regulations and guidance’s
• May require up to 5% domestic travel
   

Preferred:

• Health regulated industry regulatory experience
• Understanding of regulatory submission and approval process and applicable US and EMA regulatory guidelines
• Experience within a cross-functional team environment as an individual contributor within a matrix organization

 

The anticipated base pay range for this position in the US is $89,000 to $143,000.

 

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

This job posting is anticipated to close on November 25, 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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

#LI-Remote

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork

 

 

The anticipated base pay range for this position is :

$89,000 to $143,000

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are 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. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours  Additional information can be found through the link below.  https://www.careers.jnj.com/employee-benefits