Biologics - Regulatory - Assistant Manager / Dy Manager

Job description for the role: Responsibilities include preparing CTD/eCTD dossiers, ensuring local (CDSCO) and global (USFDA/EMA) compliance with a focus on CMC (Chemistry, Manufacturing, and Controls) and regulatory intelligence. Regulatory Strategy: Develop and implement regulatory strategies for clinical trials, and new drug/marketing authorization applications (MAA). Dossier Preparation: Prepare, review, and submit dossiers (CTD/ACTD/eCTD) to various regulatory authorities, including the CD…