Role of Regulatory Affairs in the Pharmaceutical Industry: Functions and Career Scope
Year: 2026
Type: article
Abstract: Regulatory Affairs (RA) is an essential department in the pharmaceutical industry that ensures medicines are developed, manufactured, tested, and marketed according to applicable laws and regulations. It acts as a link between pharmaceutical companies and regulatory authorities. The major functions of Regulatory Affairs include regulatory strategy, clinical-trial documentation, preparation of regulatory dossiers, drug approval, product registration, labelling, manufacturing compliance, and post-marketing surveillance. The International Council for Harmonisation (ICH) provides guidelines that help standardise pharmaceutical technical requirements, including the Common Technical Document (CTD). In India, the Central Drugs Standard Control Organisation (CDSCO) performs important regulatory functions under applicable Indian legislation. Regulatory Affairs also offers career opportunities for pharmacy graduates in pharmaceutical companies, contract research organisations, and regulatory consulting firms. This review discusses the functions, importance, career scope, challenges, and future trends of Regulatory Affairs in the pharmaceutical industry.
Language: English
Topic: Healthcare Regulation
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7225403216