100% REMOTE - Needs to support PST time zone (flexible), must support ATO site hours
Ideal Candidate
someone with a mixed background not just lab but manufacturing and process development.
This manager 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.
Title: Regulatory Project Coordinator (RPC)
Job Description
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)
Basic Qualifications
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
Top 3 Must Have Skill Sets
Change Control evaluation or owner
QA, Manufacturing or Operations background experience
Process Development experience for biotech products
Day To Day Responsibilities
Assess change control records supporting ATO and ESQ areas
Support submissions with site related documents, as requested
Provide support for variation process
Pay Rate between $52 - $60/Hr on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Legal
Industries
Biotechnology
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