Aditi Consulting · 20 hours ago

Regulatory Affairs Senior Associate

Thousand Oaks, CA

Full-time

Remote

Mid, Senior Level

$30/hr - $34/hr

Maximize your interview chances

AppsConsulting

Growth Opportunities

Insider Connection @Aditi Consulting

Discover valuable connections within the company who might provide insights and potential referrals.
Get 3x more responses when you reach out via email instead of LinkedIn.

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

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

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