Manage API DMF filing & lifecycle - US/EU/ROW
Deficiency responses
CMC documentation
Compliance with USFDA, EMA, EDQM
eCTD submissions via CDER NextGen/CESP
Coordinate with R&D;/QC/QA/Productio
Note - Robust API Regulatory Affairs background required
Required Candidate profile
Mandatory hands-on experience in API Regulatory Affairs with expertise in
DMF
ASMF
CEP
eCTD submissions
CMC documentation
Lifecycle management
Sachin
70390 15156
📌 Regulatory Affairs Manager -Exp must in API, CMC, DMF Filing (Navi Mumbai)
🏢 Job Proffer
📍 Navi Mumbai
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