Responsible for coordinating and executing communications between state, CLIA and COLA programs with Center Management. Contribute to compliance with FDA's requirements for Biological Product Deviation Reporting. The Regulatory Affairs Support Analyst will also provide guidance to Plasma Centers related to compliance with FDA regulations/guidances and international requirements. Coordinate communications to complete government mandated tasks between Center Managers, other departments, customers and regulators to facilitate information sharing and problem resolution. May participate and provide guidance in audit investigations.
Knowledge of federal guidelines is strongly desired. Detail-oriented with good analytical skills. Strong written and verbal communication skills with knowledge of scientific, medical and regulatory terms.
Bachelor’s degree in a health or science-related field with at least 1-3 years experience in Plasma industry/related field or FDA regulated industry.
Biotest Pharmaceuticals - 13 months ago