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Senior Associate of Regulatory Affairs

Bristol, TN 37620

Posted: 02/09/2024 Job Number: SG24905429 Pay Rate: $84000-96000 / year

Job Description

Do you have proficiency in the use and preparation of electronic regulatory submissions under FDA and ICH Common Technical Document (CTD). Luttrell Staffing Group is now hiring Senior Associate of Regulatory Affairs.
*This is a Direct-Hire position*
Key duties and details for Senior Associate of Regulatory Affairs:
  • Compilation and review of FDA submissions, amendments, supplements, annual reports, DMF updates, and labeling packages
  • Coordinate compilation/review of advertising and promotional material with marketing for management's review and approval
  • Submit advertising and promotional materials to FDA's OPDP via electronic methods
  • Salary: $84k - $96k per year
  • Schedule: Monday-Friday, 8am-5pm
  • Excellent benefits package

Qualifications for Senior Associate of Regulatory Affairs:
  • Bachelor's degree in a scientific area of interest (chemistry, microbiology, biology, pharmacy, premed, nursing)
  • Minimum of 4 years' direct pharmaceutical industry experience or solid equivalent work experience in a cGMP and/or FDA regulated environment
  • Ability to multi-task and manage multiple projects
  • Excellent verbal and written communications skills
  • Ability to meet deadlines
  • Formal project management skills and SAP experience are a plus
  • Experience in use of PC-based word processing software, spreadsheets, and Adobe Acrobat
  • Experience with metrics management and reporting

Please apply by clicking on the link below, then call or text (423) 764-1334.
EOE

Meet Your Recruiter

April Casaday
Staffing Coordinator

April is a staffing coordinator for Luttrell Staffing Group Bristol. If you are looking for a job in Bristol or the surrounding area, please give her a call!

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