Regulatory Affairs Manager - Exp must Be in API, CMC, DMF Filing (Mumbai)

Regulatory Affairs Manager - Exp must Be in API, CMC, DMF Filing (Mumbai)

20 Aug
|
Job Proffer
|
Mumbai

20 Aug

Job Proffer

Mumbai

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 - Solid 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 Be in API, CMC, DMF Filing (Mumbai)
🏢 Job Proffer
📍 Mumbai

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