Troikaa Pharmaceuticals - DGM/GM - Pre-Clinical Toxicology/Pharmacokinetics/Regulatory Affairs - Medical Services

DGM/GM - Medical Services (Pre-clinical Toxicology /Pharmacokinetics, Regulatory Affairs) @ Troikaa Pharma Ahmedabad

Candidate will be placed in Medical Services Department and will mainly support following activities:

Pre-clinical Activities:

- Literature search and support for pre-clinical regulatory roadmap for NDDS products

- Pre-clinical (Toxicology/ POC/ Pharmacokinetics study) Synopsis preparation and review of study plan, Justification/waiver write-up preparation for pre-clinical studies

- Pre-clinical CRO Feasibility and Selection, CDA preparation, Project contract and Work order preparation -Coordination with CROs, Study Monitoring, Invoices processing, Pre-clinical Study report review and finalization

- Knowledge of OECD GLP principles is must. Should have exposure in GLP toxicity studies

Regulatory Affairs (desirable):

- Review of CTD documents like 2.4, 2.5, 2.6 and 2.7 for dossier submission to RoW countries

- Review of RMP, PSUR, PI and SmPC