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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
Senior 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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About Bristol, TN

Begin your next career chapter in beautiful Bristol, Tennessee! Nestled in the stunning Appalachian Mountains, Bristol offers a perfect blend of southern charm and unparalleled natural beauty. Known as the "Birthplace of Country Music" and home to the iconic Bristol Motor Speedway, this vibrant city boasts a rich cultural heritage and a thriving arts scene. With an array of job opportunities across various industries and a strong sense of community, Bristol is a fantastic place to grow both personally and professionally. Explore our job listings today and discover the enchanting charm of Bristol, where new adventures await at every turn.