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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Regulatory Project Coordinator (RPC)
Remote, CA US
Posted: 09/04/2024
2024-09-04
2024-10-12
Employment Type:
Contract
Job Category: Regulatory
Job Number: 3992
Job Description
This position within CMC will facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.
Responsibilities:
Responsibilities:
- Assist Regional Regulatory Representative to support regional regulatory activities (e.g. IMPD development and submission, advisory committee meeting preparations)
- Create and maintain product regulatory history documents through IMR and appropriately archive all regulatory documents and agency communications.
- Ensure compliance with submissions regulatory agencies
- Coordinate QC of regulatory documentation (e.g. briefing packages)
- Assess change control records supporting ATO and ESQ areas
- Support submissions with site related documents, as requested
- Provide support for variation process
- Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
- Change Control evaluation or owner
- QA, Manufacturing or Operations background experience
- Process Development experience for biotech products