LiteSan, the clinical research arm of Centaur is located in Centaur House, conforms to international regulatory standards. LifeSan is fully integrated, offering end-to-end clinical research solutions from Bioequivalence and Bioavailability (BA-BE) studies to drug interaction studies to phase II, III and IV clinical trials. LifeSan caters to global leaders and leading Indian companies. LifeSan is successfully inspected by the USFDA, MHRA (UK), MCC and BfArM (Germany). LifeSan would soon be foraying into the area of pharmacovigilance. LifeSan offers world class facilities with state of the art machinery, 42 beds, a separate ICU section and is manned by 6 doctors and a well-trained and experienced staff.
Regulatory Affairs
Centaur has a highly experienced Regulatory Affairs team for compilation of DMFs, CTD/eCTD Dossiers and ANDAs for submission to regulatory authorities globally including USA/ EU/AUS/JAPAN/CANADA/ SOUTH AFRICA/MEXICO/ NEWZEALAND etc. The regulatory team is continuously updated on the global regulatory framework for organizing data generation as per the required submission norms in the territory. Centaur Regulatory Team is working on submissions of DMFs and Dossiers globally which will pave business for Centaur in the coming years. This will include domestic as well as emerging market opportunities and registration of Finished products and APIs in highly regulated and competitive markets globally.
Asst. Manager
Qualification : M.Pharm / B.Pharm / M.Sc. having 8+years experience in EU/LATAM market
Job profile :
• Responsible for the designated regulatory projects with respective deadlines
• Expertise in authoring CMC documentation for EU MAA and post-approval submissions with hands-on experience on using eCTD software
• Good coordination skills with stakeholders on regular basis to source the documents in accordance with project timelines
• Review the documents against the Agency guidances assuring regulatory compliance Keep knowledge up to date about regulatory guidelines
• Manage administration of regulatory documentation and ensure the traceability of regulatory history (filing, archiving, database etc)
Sr. Officer / Executive
Qualification : M.Pharm / B.Pharm/ M.Sc. having 4-6 years experience in US market
Job profile :
• Author and compile CMC documentation for ANDA filings and post-approval submissions
• Coordination with stakeholders on regular basis to source the documents in accordance with project timelines
• Review the documents against the FDA guidance assuring regulatory compliance Keep knowledge up to date with regard to regulatory guidelines Hands-on experience on using eCTD software.
Interested candidates can share their profile on nrane@centaurlab.com
Last Date : 15th April, 2023
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