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Regulatory Affairs Associate - Remote (JP9712)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:   Regulatory Affairs Associate - Remote (JP9712)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit: Regulatory Affairs - Promotion
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 1/26/2022
Note: 100% remote work

3 Key Consulting is hiring a Regulatory Affairs Associate for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
  • Administrative projects as backup support of Operations staff during project period 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 product regulatory history documents through IMR/Veeva and appropriately archive all regulatory documents and agency communications per process.
  • Generate Digital Asset Management (DAM) reports for vendor management program. Coordinate QC of regulatory documentation (e.g. Preclearance & Request for Advisory Comments (RFAC) submissions and other FDA communications).
  • Manage and host formal webex meetings with meeting minutes.
  • Creation of Infographics, slides, technical editing of process documents, and proofreading.
  • Create PowerPoint, Visio, manipulate data in Excel spreadsheets (including pivot tables) and author/update MSWord documents.
  • Experience in labeling and Regulatory document management. Experience in promotional review and approval process. Remote position with flexible work hours to accommodate EST/CST/PST employees project needs.

Why is the Position Open?
Supplement workload.

Top Must Have Skills:
  • Experience with Veeva PromoMats.
  • Experience with Technical Writing.
  • Communication and Contact: The employee communicates effectively both verbally and in writing with superiors, colleagues, and individuals inside and outside the Company.

Day to Day Responsibilities:
Administrative projects as backup support of Operations staff during project period 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).

Basic Qualifications:
  • 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.
  • Additional qualifications:
    • Strong business communication and organization skills
    • Detail oriented
    • MS-Office applications
    • Tableau (preferred)
    • Visio
    • Veeva PromoMats
    • Regulatory experience
    • Copy editing
    • Technical writing
    • Project Management

Employee Value Proposition:
Gain experience/ knowledge in a unique and growing environment.

Red Flags:
  • No regulatory affairs experience.
  • No college education (specific degree not required).
  • Lack of strong verbal & communication skills.

Interview process:
Video Skype Panel Interview


We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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