Sr Regulatory Affairs

Role: Sr Regulatory Affairs

Shift: 6AM-3PM IST

Location: Hyderabad

Responsibilities

• Independently prepare, review, and contribute to high-quality regulatory submissions (e.g. BLA, NMA, IND components) for biological and cell and gene therapy products, in line with ICH, FDA, EMA, TGA, and Medsafe requirements.
• Act as a core contributor or lead author for assigned CMC, clinical, and/or non-clinical sections of regulatory dossiers.
• Coordinate, compile, and author responses to regulatory questions and RFIs, ensuring clear scientific justification and adherence to timelines.
• Perform gap analyses on source documentation against applicable ICH guidelines and FDA/EMA guidances for cell and gene therapies (including CAR T-cell products), and clearly communicate gaps and risks to the Regulatory Manager and relevant SMEs.
• Support post-approval activities, including variations, amendments, and lifecycle management o...