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For your reference, we have included the original job posting below.
Compliance and Regulatory Affairs Manager - Pharma
Job Number:
26298915
Company Name:
Confidential Company
Job Location:
New Brunswick, NJ US
Job Category:
Management & Business
Salary:
$110K - $130K
Compliance and Regulatory Affairs Manager - Pharma
Regulatory Affairs and Compliance Manager - Pharmaceuticals
Global pharmaceutical leader seeks a Regulatory Affairs and Compliance manager to lead a compliance and regulatory affairs team responsible for writing and filing regulatory submissions. The Regulatory Affairs and Compliance Manager will:
Lead internal and external audits to ensure compliance with the FDA, corporate and pharmaceutical development and policies
Serve as primary point of contact for all compliance and regulatory matters
Oversee CAPA program
Oversee the site's Change Control Program
Job Requirements
Bachelor's degree in chemistry, microbiology or related scientific discipline; advanced degree preferred
5+ years of experience in quality assurance and regulatory affairs
2+ years of managerial experience
Experience auditing documents which require cGMP compliance
Expert knowledge of cGMPs and the regulations for writing and filing regulatory submissions
Excellent management skills and the ability to mentor and develop subordinates
The ability to prioritize complicated issues and to multi-task in a high pressure ever changing working environment
The ability to analyze and interpret scientific data
Excellent communications skills, oral, written and technological
