Regulatory Affairs Specialist

Role : Regulatory Affairs Associate II

Work location : Mumbai & Bangalore

Summary :

• The Associate II, Complex Gx, Regulatory Affairs is responsible for the preparation and submission of high-quality regulatory filings—both pre- and post-approval—for U.S. FDA-regulated inhalation, implant, ophthalmic, and drug-device combination complex generic products. With moderate to minimal guidance, the Associate II will manage regulatory submissions—including original applications, amendments, deficiency responses, and post-approval supplements—while collaborating closely with cross-functional teams.
• The role includes evaluating change controls, determining appropriate regulatory pathways (e.G., PAS, CBE-30, CBE-0, AR), confirming the change assessment with their regulatory manager, and submitting post-approval supplements in accordance with FDA guidelines and internal SOPs.
• The Associate II, on occasion, will also serve as a regulatory point of contact for assigned products and contribute to process improvement initiatives

Job responsibilities :

Experience & Qualification :

Regulatory, Analytical, QA, laboratory or production experience preferred.

detail oriented.

Best regards

Ankita