Regulatory affairs in the pharmaceutical industry is a profession that has developed from the desire of governments to protect public health by controlling the safety and efficacy of products, including pharmaceuticals, veterinary products, medical devices, food supplements, and more. Regulatory affairs professionals are responsible for ensuring that their organizations comply with all regulations and laws concerning their business. They play a crucial role in drug development, maintaining a vital communications link between the pharmaceutical company and regulatory agencies like the FDA in the United States, TGA in Australia, MHRA in the United Kingdom, and MCC in South Africa, to name a few. The regulatory affairs department is responsible for ensuring the quality, safety, and efficacy of therapies patients use. The role of regulatory affairs in the pharmaceutical industry includes:
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Ensuring compliance: Regulatory affairs professionals must stay current with complex regulations and often have expertise in legal, regulatory, and clinical trial environments.
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Product development: The regulatory affairs department will often take part in the development of product marketing concepts and is commonly required to approve packaging and advertising before it is used commercially.
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Communicating with regulatory agencies: Regulatory affairs professionals are key players in drug development, maintaining a vital communications link between the pharmaceutical company and regulatory agencies.
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Lifecycle management: The regulatory affairs team plays a key role throughout the product lifecycle to demonstrate the quality, control, conformity, safety, and efficacy of the product in the documentation submitted to the competent authorities for review and approval.
Regulatory affairs in pharma should be used as a tool to help manufacturers develop and market their products and that regulators and their regulations should not be feared or avoided.
