Manager - Regulatory Informatics and Operations

• 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 & uploading of “Clinical & Non-Clinical Study Reports” (Module 4 and 5) and Creating of STF, Leaf Title as per ICH Guidelines for USFDA
• 100+ BA/BE studies tagged in STF Format with CSRs, CRFs & Datasets in eCTD/ICH E3 Format
• Experience in Compilation, Publishing, Submission & Life Cycle management of e-CTD submission (NDA, ANDA, DMF) for US (US-FDA) and EU, Canada, Australia, GCC, ROW
• Aware about the current expectation of different regulatory authorities like USFDA, EU, GCC, Canada, Australia for e-CTD requirements
• Ensure Regulatory submissions with FDA ESG, EMA, CESP & MHRA gateways to submit final published eCTD sequences
• Perform quality review of Regulatory Operations team members work to ensure accuracy and to maintain quality delivery of all assigned projects
• Involved in end-to-end Regulatory Operations activates such as per-doc, publishing, submission, validation, dispatch & archival
• Team Management

• 13 years of relevant experience
• B.Pharm or other Science degree, M.Pharm preferred
• Submission publishing (mandatory) US Publishing experience
• Veeva tool experience (preferred) Veeva Publishing experience
• Must be open to working in shifts if required

Veeva tool experience (preferred) Veeva Publishing experience