CTX Lifesciences Pvt. Ltd - Urgent Openings for Regulatory Affairs Department - Apply Now
Executive / Asst. Manager with 5 To 10 Years of Exp. in RA Dept.
Company: CTX Lifesciences Pvt. Ltd.
Experience: 5-10 years
Qualification: B.Sc / M.Sc / B.Pharm / M.Pharm
Location: Surat
Job Description:
Good Exposure on Submission of Drug Master File in eCTD format for Europe and US market.
Application for Certificate of Suitability [CEPs] dossier for EDQM.
Exposure on Query responses received from EDQM, USFDA and other EU countries and customers.
Application for Certificate of Suitability [CEPs] dossier for EDQM.
Exposure on Query responses received from EDQM, USFDA and other EU countries and customers.
Required Candidate profile
Exposure on European Drug master Files (EDMFs/ASMFs) in conjunction to the Decentralized Procedures (DCPs), Mutual Recognition Procedures (MRP) and National Procedures.
Life cycle management of DMFs.
Life cycle management of DMFs.
You can reach us: http://www.ctxls.com // 0261-2399669 /2398456 /90990 75796
Email : hrd@ctxls.com / career@ctxls.com
Email : hrd@ctxls.com / career@ctxls.com
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