Regulatory Systems Business Support Manager
A biopharmaceutical company based in West Dublin is seeking a skilled professional to manage the migration of regulatory information from an existing Veeva system to a new RIM system.
Key Responsibilities:
* Ensure successful deployment of migration strategies.
* Maintain compliance with relevant regulations and internal policies throughout the migration process.
* Offer technical knowledge and insight to enrich regulatory data if necessary.
Qualifications and Experience:
* Bachelor's degree in a relevant field.
* Minimum 4 years of experience in the pharmaceutical/biotech industry, specifically in Global Regulatory Affairs, Clinical or Regulatory Operations, supporting systems.
* Experience working within a Veeva Regulatory Information Management system is essential.
* Prior knowledge of electronic document management systems, regulatory publishing systems, and regulatory tracking databases is beneficial.
* Familiarity with GxP, Annex 11, and 21 CFR Part 11 computerized systems is required.