National Occupational Standard for Regulatory Affairs Manager in Bio-Health

Definition of Occupation

The Regulatory Affairs Manager in Bio-health collaborates strategically throughout the organization’s product life cycle in order to ensure that new and existing products such as drugs, cosmetics, medical devices, and nutritional products comply with applicable rules, regulations, and industry standards. They are involved in risk assessment and management to ensure products meet research standards and quality, efficacy, and safety requirements. They provide advice on the regulatory boundaries in the commercialization process. Regulatory Affairs Managers in Bio-health are responsible for the process of obtaining and maintaining government approval for the products. They represent the organization’s interests and objectives while interacting and negotiating with regulatory agencies. The Regulatory Affairs Manager may also provide input and feedback on proposed government regulations directly and/or through their association.

The duties and responsibilities of the Regulatory Affairs Manager in Bio-health have expanded in recent years as a result of acquisitions and restructuring, worldwide globalization of markets, and constantly evolving legal, technical, and scientific requirements. They work within a dynamic work environment where communication with employees at all levels and within different
departments is extremely important. The Regulatory Affairs Manager in Bio-health not only ensures regulatory compliance but works to foster a positive regulatory culture within the organization.

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