Regulatory Affairs Specialists in India's pharmaceutical industry prepare and manage submissions to global regulatory bodies — USFDA (ANDA, NDA, 505(b)(2), DMF), CDSCO/DCGI (Form 44, CTD dossiers), EMA (MAA via eCTD), and MHRA — for generic, branded, and biosimilar products. The role sits at the intersection of CMC science, law, and project management: an RA specialist at Sun Pharma, Dr Reddy's, Cipla, Lupin, Aurobindo, or Biocon will spend most of their day navigating GDUFA timelines, responding to USFDA deficiency letters, preparing post-approval change submissions (PAS, CBE-30, Annual Reports), and maintaining CDSCO dossier currency across a product portfolio spanning tablets, injectables, dermatological formulations, and biologics. India's generic export engine — responsible for ~30% of USFDA-approved generic drugs by volume — makes this one of the most India-specific, globally consequential pharma functions. Entry paths include B.Pharm/M.Pharm (PCI-recognised), RAC certification (Regulatory Affairs Professionals Society, RAPS), and Post Graduate Diplomas in Regulatory Affairs from NIPER, Manipal, or Symbiosis.