Master degree in Pharmacy, Clinical Pharmacology, Pharmacy Practice, and Clinical Research. OR Pharm. D/ MBBS/BDS from a recognised university/institute.
M.Pharm / M.Tech with minimum six months research experience in injectable formulations. Industrial or academic research in injectable or other formulations, with experience would be preferred but is not mandatory.
M.Sc/ B.Pharm / M.Pharm. To plan, prepare and review of high quality dossier with support and guidance, assuring technical concurrency and regulatory compliance, meeting agreed upon timeline.
Doctor of Philosophy (Ph. D) Degree in the relevant field from a recognized University / Institution and first class or equivalent at either Bachelors or Masters level in the relevant branch.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
Managing initial clinical trial application submissions in the EU according to the Clinical Trial Regulation and all changes during the life cycle of clinical trials.