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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Senior Associate, Regulatory Affairs
Remote, CA US
Posted: 11/20/2024
2024-11-20
2025-01-08
Employment Type:
Contract
Job Category: Regulatory
Job Number: 4150
Job Description
Our client is looking to add a Sr. Associate, Regulatory Affairs to their team on a contract basis. Contract term: 12 months with possible extension.
Responsibilities:
Qualifications:
Performance Factors:
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).
- 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).
- Lead and manage WebEx meetings and provide meeting minutes.
- 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).
- Create PowerPoint, Visio, manipulate data in Excel spreadsheets (including pivot tables) and author/update MSWord documents.
Qualifications:
- Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
- Ability to lead and manage WebEx meetings and provide meeting minutes.
- Project Management experience.
- Experience with Jira, Kanban.
- Experience with the creation of Infographics, slides, technical editing of process documents, and proofreading.
- Experience in labeling and Regulatory document management.
- Experience in promotional review and approval process.
- Strong business communication and organization skills.
- Proficient in MS-Office applications, Tableau (preferred), Visio, Veeva PromoMats.
Performance Factors:
- Relationships with Others: The employee works effectively and relates well with others including superiors, colleagues, and individuals inside and outside the Company. The employee exhibits a professional manner in dealing with others and works, to maintain constructive working relationships.
- Communication and Contact: The employee communicates effectively both verbally and in writing with superiors, colleagues, and individuals inside and outside the Company.
- Dependability: The employee can be depended on to complete work in a timely, accurate, and thorough manner and is conscientious about assignments.
- Ability to read and understand written instructions and follow documented process independently
- Proactively handling tasks by monitoring upcoming activities or assisting with daily team workload responsibilities.