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
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.
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.
You can reach us: http://www.ctxls.com // 0261-2399669 /2398456 /90990 75796
Email : email@example.com / firstname.lastname@example.org
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube