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Regulatory Affairs Business Analyst

2 weeks ago

India beBeeRegulatory Full time
Business Analyst - Regulatory Affairs Specialist

We are seeking an experienced Business Analyst with a strong background in regulatory affairs to support our pharmaceutical operations and digital transformation initiatives. The ideal candidate will have a deep understanding of regulatory processes and documentation, as well as the ability to work closely with cross-functional teams to drive system implementation and optimization.

  • Gather and document business requirements related to regulatory systems and workflows.
  • Act as a liaison between regulatory affairs and IT teams, translating business needs into actionable system enhancements.
  • Drive implementation and optimization of regulatory systems: submissions, registrations, submissions archive, and product.
  • Analyze existing regulatory processes and recommend digitization/improvement opportunities.
  • Support data migration, configuration, validation, and user acceptance testing (UAT) of regulatory systems.
  • Document business requirement documents (BRD), functional requirement documents (FRD), use cases, process flows, and traceability matrices.
  • E nsure compliance with global regulatory requirements (e.g., FDA, EMA, ICH).

Required Skills & Qualifications:

  • 6+ years of experience as a Business Analyst in the Pharmaceutical or Life Sciences domain.
  • Minimum 2 years hands-on experience in Veeva Vault RIM (Submissions/Registrations/Product modules).
  • Strong understanding of Regulatory Affairs processes: submission lifecycle, labeling, lifecycle management, compliance.
  • Proven experience in requirement gathering, documentation, and stakeholder management.
  • Familiarity with eCTD, IDMP, XEVMPD, and GxP compliance.
  • Experience with CSV/validation support is a plus.
  • Excellent communication, presentation, and analytical skills.

Nice-to-Have:

  • Experience with other regulatory systems (e.g., ArisGlobal, Lorenz docuBridge, MasterControl).
  • Exposure to Agile/Scrum methodologies.
  • Knowledge of Veeva Vault Quality or PromoMats is a bonus.