Must have through knowledge on DMF filing procedures to various regulatory authorities such as USFDA, entire Europe, Australia, Canada etc. Should have ability to independently compile ......
Designation : MANAGER/SR.MANAGER - REGULATORY AFFAIRS - API
Company : Lee Pharma Limited
Experience : 8 - 12 Years
Location: Hyderabad / Secunderabad
Education: UG - Pharma,B.Sc - Chemistry
PG - Pharma,M.Sc - Chemistry
Job Description
Must have through knowledge on DMF filing procedures to various regulatory authorities such as USFDA, entire Europe, Australia, Canada etc. Should have ability to independently compile various sections of DMF such as Administrative module, QOS.
Desired Profile
Through knowledge on DMF amendment, annual updates, variation filings procedure to the regulatory authorities as per the respective country requirement.ability to independently access change proposal from regulatory respective. DMF compilation skills
Reach Us
Assist.Manager HRD
Lee Pharma Limited
Ref ID : Manager/Sr.Manager RA API
hrd@leepharma.com
http://www.leepharma.com
Please forward resumes to hrd@leepharma.com
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