Required Technical Skills:

• 3–5 years of experience as a Business Analyst in Regulatory Affairs, Regulatory, or Life Sciences systems.
• Hands-on exposure to RIM platforms (AgilePV, Veeva RIM, ArisGlobal RIMS, Ennov, etc.) or equivalent regulatory systems.
• Experience working with submission dossiers (eCTD/CTD), sequences, and lifecycle management.
• Understanding of EMA, FDA, and ICH regulatory submission requirements.
• Strong ability to translate regulatory processes into system requirements and workflows.
• Experience writing user stories, functional specifications, test cases, and validation evidence.
• Familiarity with controlled vocabularies (SPOR, XEVMPD, IDMP preferred).
• Excellent communication and stakeholder-facing skills.