Regulatory Affairs Biologicals Senior Specialist Apply
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
