Regulatory Affairs Manager - Exp must Be in API, CMC, DMF Filing
Job Proffer · Mumbai · onsite · Posted 70d ago
₹25.0L - ₹30.0L PA12–20 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
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 - Strong API Regulatory Affairs background required
DMF
ASMF
CEP
eCTD submissions
CMC documentation
Lifecycle management
Sachin
[phone removed]
Deficiency responses
CMC documentation
Compliance with USFDA, EMA, EDQM
eCTD submissions via CDER NextGen/CESP
Coordinate with R&D/QC/QA/Productio
Note - Strong API Regulatory Affairs background required
Required Candidate profile
Mandatory hands-on experience in API Regulatory Affairs with expertise inDMF
ASMF
CEP
eCTD submissions
CMC documentation
Lifecycle management
Sachin
[phone removed]
Sourced from naukri
Skills
API Regulatory AffairsICH guidelinesEMAUSFDACMC documentationDrug Master File