Experienced RA Professional, Digital Regulatory Scientist

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

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Dallas, Texas, 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

We are searching for the best talent for an Experienced RA Professional, Digital Regulatory Scientist.

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:
The Digital Regulatory Scientist will play a pivotal role in transforming regulatory submission processes through digital innovation. This position bridges business needs with technology solutions, driving efficiency, compliance, and continuous improvement across global regulatory operations.

You will be responsible for:
 

• Process Optimization & Continuous Improvement
  • Drive continuous improvement of regulatory submission processes, roles, and workflows across global markets.
  • Lead initiatives to realign responsibilities, identify synergies, and optimize end-to-end submission content processes considering regional regulatory requirements.
  • Map and maintain global process documentation to ensure clarity, compliance, and consistency across regions.
• Digital Transformation & Innovation
  • Identify high-value scopes of work for digitalization, automation, or transfer to other organizational teams, ensuring scalability for global operations.
  • Bridge global business needs with technology solutions to enable digital transformation in content operations.
  • Gather and validate business and user requirements for new tools, automations, and processes across diverse geographies.
  • Partner with IT, Digital Innovation, and regional process leads to design and deploy technology solutions that meet global standards.
• Strategic Collaboration & Governance
  • Collaborate closely with Regulatory Affairs and Digital Innovation teams worldwide to align improvements with broader global strategies.
  • Support prioritization and funding decisions for digital initiatives with consideration of global impact and regional variations.
  • Serve as a liaison between global operations, regulatory functions, and technology teams to ensure seamless integration.
• Value Tracking & Compliance
  • Track and report value realization from digital transformation initiatives across all regions.
  • Ensure high standards of delivery, compliance, and continuous improvement globally, adhering to international regulatory frameworks.
     

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
• Basic understanding of the drug development process and product life cycle from discovery through marketing and post-approval requirements, with the capability to interpret and apply local regulations and guidance's.
• Basic understanding of regulatory submission processes and global compliance requirements.
• May require up to 5% domestic travel.
   

Preferred:

• Previous health regulated industry regulatory experience
• Familiarity with automation tools, content management systems, and regulatory technology platforms.
• Experience in process optimization, digital transformation, and technology deployment.
• Stakeholder management and communication skills in a global, cross-functional environment.
• Ability to translate complex business needs into actionable technology solutions across diverse markets.
• Strategic thinking with a global perspective on innovation and efficiency.
• Strong analytical, problem-solving, and documentation skills.
  
  

The anticipated base pay range for this position in the US is $92,000 to $148,000.

 

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:
 

This job posting is anticipated to close on November 27, The Company may however extend this time-period, in which case the posting will remain available on 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 , 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

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