Associate- Regulatory Affairs

Added
8 days ago
Type
Full time
Salary
Salary not provided

Related skills

tableau data visualization data entry power bi regulatory affairs
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📋 Description

  • Review and manage all regulatory events (changes) initiated within the Veeva Vault RIM system.
  • Perform system impact assessments for regulatory changes and ensure accurate documentation of
  • Create and maintain regulatory Activities, Regulatory Objectives, Submissions, Global Content
  • Ensure proper linkage and completeness of Event Details, Change Items, and Label Concepts within
  • Support CMC Product Strategists, Labelling Leads, and Country Regulatory Strategists through both
  • Assist in lifecycle management of regulatory submissions and registrations across multiple regions.

🎯 Requirements

  • Bachelor’s or master’s degree in B. Pharm, M. Pharm, Pharm.D, B.Sc (Life Sciences), M.Sc (Life
  • 0–3 years of relevant experience in RIM, preferably with hands-on exposure to Veeva Vault RIM.
  • Strong understanding of regulatory systems, data structures, and end-to-end regulatory change
  • Experience with data visualization tools such as Tableau or Power BI
  • Strong analytical and problem-solving skills with high attention to detail and accuracy.
  • Excellent communication and stakeholder management skills.
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