Schedule and assign projects to Regulatory Affairs team to ensure business timelines are met. Review, compile and dispatch new product submissions and pre-launch variations.
BA / BS degree with at least 3 years clinical trial experience or direct equivalent experience or advanced degree (MS / PhD /PharmD ) with at least 2 years clinical trial experience.
looking for a meticulous professional to lead drug product manufacturing and sterile formulation operations, ensuring adherence to Current Good Manufacturing Practice, cGMP and safety norms.
B.Pharm / MSc; To perform the calibration of QC instruments as per calibration schedule. Overall upkeep of respective working bench as well as of the section as per GLP.
Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. Exposure of the Sterile dosage form / complex injectable dosage form and brief manufacturing process and key regulatory aspects. Amneal Pharmaceuticals. Qualification : B.Pharm, M.Pharm
Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for submission to various health authorities like – US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.
Pharmacovigilance Scientist, Senior Scientist ensures regulatory compliance and safety of Takeda's products by managing large projects, developing innovative solutions, and leading teams. This role contributes to the development and execution of pharmacovigilance strategies, ensuring patient safety and regulatory adherence