Hiring for regulatory affairs (US market) at Centaur Pharma - Experienced candidates only

In 1978, 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.

Hiring for regulatory affairs (US market)

Position: Asst. Manager
Qualification: M.Pharm/B.Pharm/M.Sc.having 10+ years
Job profile
• Responsible for the designated regulatory projects with respective deadlines
• Expertise in authoring CMC documentation for ANDA filings 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 FDA guidance 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)

Position: Sr.Officer/ Executive/ Sr.Executive
Qualification: M.Pharm/B.Pharm/M.Sc. having 4-7 years experience in US market Jc
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 projecttimelines
• Review the documents against the FDA guidance assuring regulatory compliance
• Keep knowledge up to date about regulatory guidelines
• Hands-on experience on using eCTD software