Senior RA Professional, Submissions, CAPAs

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 Product Submissions and Registration

Job Category:
Professional

All Job Posting Locations:
Raritan, New Jersey, United States of America, Titusville, 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 a Senior RA Professional, Submissions, CAPAs.

This hybrid work position will be located in Raritan, NJ or Titusville, NJ.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to follow local requirements.

While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).


* Warsaw, Poland; Leiden, The Netherlands - Requisition Number: R-034278


* High Wycombe, United Kingdom - Requisition Number: R-036049

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

The CAPA Lead is a strategic role within the Next Gen Submissions (NGS) function, responsible for driving quality, compliance, and continuous improvement across the regulatory submissions lifecycle and publishing lifecycle.

 This role ensures that CAPA activities are executed in compliance with applicable regulatory requirements, company policies, and industry best practices.

The CAPA Champion acts as a subject matter expert, coach, and facilitator—supporting cross-functional teams to identify root causes, implement robust corrective/preventive measures, and verify long-term effectiveness.

Main Duties and Responsibilities:

~50% of time:
CAPA Oversight


* Serve as the Next Gen Submissions lead for the CAPA process, ensuring timely initiation, investigation, implementation, and closure of Non-Conformances and CAPAs.


* Monitor CAPA progress, provide guidance on documentation quality, and ensure compliance with regulatory requirements (e.g., FDA, EMA, ICH, ISO sta...