Valeant Pharmaceuticals

Regulatory Affairs Specialist (Operations)

Location US-NJ-Bridgewater
Job ID
Pos. Type
Full Time


Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.


The Regulatory Affairs Operations Specialist is responsible for updating global regulatory information in Global RIM system, and generating relevant reports from the system. The person will also assist the electronic/paper compilation and submittal of Regulatory submissions to Health Authorities.


Update regulatory data in Global RIM system, and assist publishing regulatory submission documents for global submissions


  • Update regulatory data in RIM systems and generate reports from the system.
  • Archive documents according to archiving and document retention strategies
  • Promote and support RA system usage
  • Work with RA Ops managers to ensure readiness of submission documents in accordance with agency guidance
  • Perform QA/QC for submission documents and deliverables for submission-readiness
  • Promote document authoring standards
  • Other job responsibilities as needed
  • Key Relationships: Internal business functions related to managing global regulatory information, and publishing global regulatory submission documents


  • Working knowledge and understanding of regulatory requirements and regulations
  • Understanding of the drug development process
  • Working knowledge of electronic submission requirements to Health Authorities
  • Knowledge of good documentation practices and requirements for managing regulated records
  • Capable of utilizing IT systems supporting regulatory affairs such as document management, electronic publishing, and submission systems (e.g., SharePoint, Documentum, InSight Manager)
  • Skilled in basic technologies (e.g., MS Office Applications, Adobe Acrobat, MS Project)
  • Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
  • 2+ years combined pharmaceutical experience and regulatory experience preferred
  • Bachelor’s degree preferred

Be Aware of Recruiting Fraud

Valeant is an EEO/AA employer M/F/D/V.


Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.


To learn more please read Valeant’s Job Offer Fraud Statement.


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