Titan Laboratories Pvt. Ltd. is the one of select few Company in India with dedicated state of art WHO GMP facility for producing high quality Sustained and Modified Release Pellets, DC Granules& Taste Masked Granules.
Position: Sr.Executive / Executive / Officer
1) Dossier Preparation ACTD/CTD/Country Specific for domestic or international market (CIS , Franko West Africa & South Est Asia market) &to ensure error free & timely submissions as per marketing Dept. timeline.
2) To evaluate & respond to any regulatory query, customer requirements that may arise from health authority so as to satisfy the query.
3) Dossier Checking of subordinates in ACTD/CTD/Country Specific format.
4) To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R&D/ADL against DMF/Dossier requirements.
5) To Co-ordinate /to visit with respective dept. in HO /Plant /ADL/R&D for documents & samples required for dossier / registration purpose.
6) Co-ordination with API /PM vendors to resolve technical quires w.r.t. regulatory requirements .
7) Artwork Checking & development for registration and commercial purpose as per regulatory requirement.
8) To Maintain & Update all documentation & dossier record; to update registration status.
Location: Ghatkopar, Mumbai, Mahad
Experience: 3-7 Years
Educational Qualification: B.Sc, M.Sc, B.Pharmacy, M.Pharmacy
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