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Contract Position - Regulatory Affairs Biologicals Senior Specialist in Athens, GA

In Georgia / United States

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Contract Position - Regulatory Affairs Biologicals Senior Specialist in Athens, GA   

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JOB TITLE:
Contract Position - Regulatory Affairs Biologicals Senior Specialist in Athens, GA
JOB TYPE:

JOB SKILLS:
JOB LOCATION:
Athens Georgia / United States

JOB DESCRIPTION :
This is a Regulatory Affairs Biologicals Senior Specialist contract position at our Direct Client site in Athens, GA
Duration: 24 months
Pay: $28.5/hr
Duties:
  • Support organization, archiving and retrieval of regulatory documents and correspondence
  • Prepare, track and finalize requests for experimental product shipments/studies
  • Develop/review work instructions consistent with regulatory organization and streamlined processes
  • Assist management of company circulation of all regulatory documents
  • Assist in assembling, reviewing, and uploading of electronic submissions to government agency in web based portal
  • Provide regulatory assessments for proposed business and manufacturing changes related to approved biological products in compliance with USDA and international guidelines and regulations
  • Review draft regulatory texts, appropriately comment and propose amendments to draft requirements in alignment with company needs.
  • Manage and provide oversight for assembly, review, formatting, circulation, approval, and submission of CMC/Outlines of Production, Special Outlines, and facility documents to the Center for Veterinary Biologics (CVB) to support compliance and variations
  • Help to assemble and provide final QA review for electronic submissions to government agencies through government portal(s) including updating documents to required templates and compliance with electronic record keeping
  • Maintain regulatory databases, activities charting, and government submission and response tracking
  • Support responding to government agencies' questions
  • Provide support for miscellaneous project assignments, as needed

Skills:
  • Proficient with Microsoft Word, Excel and Adobe, team oriented with excellent written communication skills, and scientific/regulatory background or education Years of experience desired: 2 years in related industry

Education: Bachelor's degree in science, Master's degree in science preferred

Position Details

S16174661819913846
Georgia / United States
Athens
A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Contract Position - Regulatory Affairs Biologicals Senior Specialist in Athens, GA    Apply

Click on the below icons to share this job to Linkedin, Twitter!

This is a Regulatory Affairs Biologicals Senior Specialist contract position at our Direct Client site in Athens, GA
Duration: 24 months
Pay: $28.5/hr
Duties:
  • Support organization, archiving and retrieval of regulatory documents and correspondence
  • Prepare, track and finalize requests for experimental product shipments/studies
  • Develop/review work instructions consistent with regulatory organization and streamlined processes
  • Assist management of company circulation of all regulatory documents
  • Assist in assembling, reviewing, and uploading of electronic submissions to government agency in web based portal
  • Provide regulatory assessments for proposed business and manufacturing changes related to approved biological products in compliance with USDA and international guidelines and regulations
  • Review draft regulatory texts, appropriately comment and propose amendments to draft requirements in alignment with company needs.
  • Manage and provide oversight for assembly, review, formatting, circulation, approval, and submission of CMC/Outlines of Production, Special Outlines, and facility documents to the Center for Veterinary Biologics (CVB) to support compliance and variations
  • Help to assemble and provide final QA review for electronic submissions to government agencies through government portal(s) including updating documents to required templates and compliance with electronic record keeping
  • Maintain regulatory databases, activities charting, and government submission and response tracking
  • Support responding to government agencies' questions
  • Provide support for miscellaneous project assignments, as needed

Skills:
  • Proficient with Microsoft Word, Excel and Adobe, team oriented with excellent written communication skills, and scientific/regulatory background or education Years of experience desired: 2 years in related industry

Education: Bachelor's degree in science, Master's degree in science preferred