Regulatory Affairs Specialists coordinate the preparation, review, and submission of regulatory dossiers for drug approval and lifecycle management. They interpret regulatory guidelines, maintain compliance with international authorities, and collaborate with R&D, quality assurance, clinical teams, and manufacturing units. Their responsibilities include preparing CTD/eCTD submissions, tracking regulatory changes, managing post-approval variations, and ensuring continuous product compliance. This role is vital for pharmaceutical companies as global markets expand and regulatory frameworks evolve. Demand remains strong with increasing complexity of biologics, medical devices, combination products, and global regulatory harmonisation efforts.