Regulatory Affairs — Regulatory Information Management & Submissions REGULATORY AFFAIRS

RIM / SUBMISSIONS12–15 YEARS UK-BASED

- Lead requirements gathering, process mapping, and gap analysis for Regulatory Information Management engagements Registrations, Submissions, Submissions Archive, and Publishing (Veeva Vault RIM or equivalent platforms such as ArisGlobal, Extedo, Generis CARA). Act as the primary liaison between Regulatory Affairs/Operations business stakeholders and IT/platform implementation teams, translating regulatory business needs into functional specifications and configuration requirements. Facilitate requirements and design workshops with client regulatory, quality, and IT stakeholders; document current-state and future-state process flows, user stories, and business/functional requirements (BRD/FRD/URS). Support IDMP/SPOR readiness and regulatory data standardization workstreams data mapping, cleansing, and enrichment against global regulatory data standards. Own requirement traceability across the delivery lifecycle from requirements through configuration, validation (CSV), UAT, and go-live — ensuring alignment with GxP and computer system validation expectations. AVE QUALIFICATIONS 12–15 years of overall experience,



with a minimum of 6–8 years directly in pharmaceutical regulatory affairs, regulatory operations, or regulatory information management gained at a pharma manufacturer, CRO (e.g., IQVIA, Parexel, ICON), a RIM systems integrator, or an IT/domain consulting firm (e.g., Accenture, Cognizant, Deloitte, Capgemini).
- — Veeva Vault RIM (Registrations, Submissions, Publishing, Archive) strongly preferred; exposure to ArisGlobal, Extedo, gathering and documenting business/functional requirements (BRD/FRD/URS, user stories), facilitating workshops, and building process maps (as-is/to-be, BPMN or swim-lane). NICE-TO-HAVE / PREFERRED
- Prior experience specifically with AstraZeneca or a comparable top-20 pharma regulatory affairs function, as client or employer.

Veeva

Vault RIM configuration or implementation certification, or direct experience on a Vault RIM implementation/migration programme.

- Exposure to regulatory process mining or digital-twin approaches to submission process redesign. Experience with Agile delivery practices (Jira, Confluence) in a regulated life sciences context. CCDM/CCDS or equivalent regulatory/clinical data management certification.

📌 Architect (Chennai)
🏢 Virtusa
📍 Chennai