The Regulatory Affairs organization within a biotech/pharmaceutical/medical device company holds the overall responsibility of ensuring that the sponsor company adheres to and complies with all regulations and laws set forth by the United States Food and Drug Administration (FDA) pertaining to the company’s product.
Regulatory Affairs organizations are comprised of people with titles such as: Manager/Director/Vice-President of Regulatory Affairs; Regulatory Affairs Associate I/II; Senior/Principal Regulatory Affairs Associate/Specialist; Regulatory Affairs Coordinator/Administrator.
The Quality Assurance organization within a biotech/pharmaceutical/medical device company holds the overall responsibility of ensuring that the integrity of the product meets the FDA’s standard for its proposed use. These standards include – but are not limited to – the product’s development, manufacturing and distribution.
The Quality Assurance organizations are comprised of people with titles such as: Manager/Director/Vice-President of Quality Assurance; Quality Assurance Specialist I,II; Quality Assurance Associate I/II; Principal Quality Assurance Specialist Associate.
Additionally, there are compliance functions that reside in the Quality Assurance organization whose purpose is to ensure compliance with GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices)and GCP (Good Clinical Practices) standards.