Regulatory Affairs Specialists ensure compliance with pharmaceutical regulations and standards. They prepare and submit regulatory documents, coordinate with health authorities, and ensure that pharmaceutical products meet all legal requirements for safety, efficacy, and quality throughout their lifecycle from development to post-marketing surveillance.
₹4,50,000 - ₹25,00,000 per annum (depending on experience, expertise, and organization)
Regulatory Affairs Specialists are in high demand as pharmaceutical companies navigate increasingly complex global regulatory environments. With new regulations emerging and the expansion of pharmaceutical markets worldwide, companies need skilled professionals who can ensure compliance and facilitate product approvals across different regions.
Regulatory Affairs Specialists typically work in office settings, often interacting with multiple departments including R&D, quality, clinical, and manufacturing teams. The role involves substantial documentation work, regulatory research, and communication with health authorities. They may work for pharmaceutical companies, regulatory consulting firms, or government health agencies.