Job Description

Responsible to submit error free dossier within timeline to reporting Manager Responsible to gather data related for dossier through online sources, laboratories, manufactures etc Responsible to do Analytical Method Validations, Process validations, analytical data & other outsource data. To assist senior regulatory personal in derivating formulas for our products To resolve queries related to dossier within timeline received from regulatory authorities To ensure company\'s regulatory policies are in sync with standard healthcare guidelines To assist in registration of imported pharmaceutical products To prepare documents for Legal. To take necessary follow-ups with the Artwork department for the registration artwork. To prepare dossier of ACTD/CTD/Country specific and ensure they are accurate enough for submission To review and update necessary changes in dossier prepared by junior regulatory team if needed To support junior regulatory team in preparation of dossier To stay updated with country specific healthcare sector government guidelines To prepare, maintain and update country guidelines in excel sheet at regular intervals To prepare, maintain and update checklist for preparing dossier documents To train regulatory team technically Requirements / Eligibility Criteria :- Education: B.Pharm/M.Pharm Experience: Minimum 3 to 5 years of experience Skills: Leadership Ability Team handling Time management Research and Data sourcing Attention to details Reading Good grip over drafting of documents Strong hold over English Language Long attention span Organizing

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