Centaur Pharmaceuticals – Multiple Positions in Regulatory Affairs / Bioanalytical Department

Centaur Pharmaceuticals – Multiple Positions in Regulatory Affairs / Bioanalytical Department – Apply Now

Centaur Pharmaceuticals, commenced pharmaceutical manufacturing operations in Mumbai and has now evolved into a vertically integrated pharmaceutical company. Centaur House, our corporate headquarters, is located in Mumbai, the commercial capital of India. Centaur has a strong matrix of capabilities across the pharmaceutical value chain including API, formulations, Contract Research and Manufacturing Services, Clinical Research, R&D, regulatory and marketing. Exports to 96 countries across five continents, is vindication of Centaur’s commitment to quality, and global acceptance by discerning doctors, patients and clients. Forty two percent of our sales accrue from international markets.

We are hiring urgently multiple positions for our Regulatory Affairs / Bioanalytical department

Regulatory Affairs

Centaur has a highly experienced Regulatory Affairs team for compiling 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 and 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 the 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 in using eCTD software
Good coordination skills with stakeholders regularly to source the documents by 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 the US market

Job profile :

Author and compile CMC documentation for ANDA filings and post-approval submissions
Coordination with stakeholders regularly to source the documents by project timelines.
Review the documents against the FDA guidance, assuring regulatory compliance. Keep knowledge up to date concerning regulatory guidelines Hands-on experience in using eCTD software

Interested candidates can share their profiles on nrane@centaurlab.com