Aditi Consulting · 16 hours ago

Regulatory Affairs Senior Associate

Thousand Oaks, CA

Full-time

Remote

Mid, Senior Level

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Responsibilities

Assist US Promotion Regulatory Representatives to support US Promotion Regulatory activities (e.g. Abbreviated Reviews and system updates for label changes, Regulatory Information Management (RIM) archiving and other process documentation authoring support, Veeva data entry and collection). Create and maintain records in Veeva and SharePoint.

Appropriately archive all regulatory documents and agency communications per process regulatory documentation (e.g. Preclearance & Request for Advisory Comments (RFAC) submissions and other FDA communications).

Ability to lead and manage Webex meetings and provide meeting minutes.

Qualification

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Veeva system experienceProject managementMS-Office applicationsRegulatory experienceTechnical writingCopy editingTableauVisio

Required

Strong business communication and organization skills

Detail oriented

MS-Office applications

Veeva Promo Mats

Regulatory experience

Copy editing

Technical writing

Project Management

Veeva system experience for both PromoMats and Regulatory Information Management (RIM) vaults

Project managing experience by proactively handling tasks by monitoring upcoming activities or assisting with daily team workload responsibilities and ability to read and understand written instructions and follow documented process independently

Create PowerPoint, Visio, manipulate data in Excel spreadsheets (including pivot tables) and author/update MSWord documents and Creation of Infographics, slides, technical editing of process documents, and proofreading