Pay: $60/hr + Benefits: Med/Den/Vis, Sick Time, 401k
Job Description:
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
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)
Experience Requirements:
Bachelor's Degree in related
MUST HAVE experience in the following: Change Controls (evaluation or owner), QA/Manufacturing/Operations background, Process Development experience for biotech products
Ideally, a mixed background with both manufacturing, lab, and process development
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Legal, Quality Assurance, and Science
Industries
Biotechnology Research, Hospitals and Health Care, and Pharmaceutical Manufacturing
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