|Reg Affairs Consultants: max pay rate is $40/hr Responsibilities: Support Regulatory Affairs CMC Manager in managing and maintaining regulatory documentation for approved regulatory applications and licenses. |
• Position requirements: Excellent organizational, communications, and document research skills a must. This position also requires teamwork, problem-solving, ability to multi-task and motivate resources in the gathering of information required. Comprehensive coordination and compilation of documentation. This person must be able to work independently with minimal guidance. Computer literacy is a must (e.g. MS Word, MS Excel, and Adobe Acrobat).
• Education: Minimum BA or BS required, preferably in a scientific or health related discipline.
• Experience: Minimum of 3 years experience in Regulatory Affairs CMC with a Pharma company. Understanding of related disciplines in a FDA regulated environment. Familiar with CMC-relevant FDA databases.