Manager - Regulatory Informatics and Operations

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

Responsibilities

• Create compile and validate e-CTD and Nees including Original Submissions i.e. NDA, IND, ANDA, DMF, BLA, MAAs, IMPD for USFDA, Canada, TGA GCC, EU, etc.
• Expertise in eCTD Submission managements, planning, publishing strategy and repository.
• Involved in Pre-Approval & Post-Approval Submissions i.e. Amendment, Variations, (FRC, DRL, IR, and CR, Type II Variation) and Post-Approval (CBE-0, CBE-30, PAS and AR, Renewals, labelling supplements), PADER, DSUR, PSUR, OPDP, REMS, DMF submission and Review & up...