National Occupational Standard for Regulatory Affairs Associate in Bio-Health

Definition of occupation

The Regulatory Affairs Associate in Bio-health works under the guidance of a manager or external expert to provide regulatory support to the development of new products and maintenance and care of existing marketplace products in the biotechnology industry. They execute the organization’s interests and objectives while interacting with regulatory agencies, and work to ensure product and organizational regulatory compliance in the pre- and post-approval stages. They seek to anticipate risks associated with regulations related to product development; contribute to the development of new regulations, policies, and guidelines; help ensure the quality and safety of the product; make recommendations on how products are sold and promoted; and help ensure products meet research standards and quality.

Under the guidance of a manager, the Regulatory Affairs Associate in Bio-health works on the development and completion of a variety of documents to ensure regulatory compliance. They maintain regulatory information systems both electronically and in hard copy, as applicable. They help to ensure that documents are accurately presented, scientifically sound, and encompass all relevant material necessary for a complete submission while still representing the best interests of the organization. They adhere to regulatory Standard Operating Procedures (SOPs), operational SOPs, and internal departmental procedures, and help identify necessary revisions.

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