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

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

02 Sep
|
Job Proffer
|
Mumbai

02 Sep

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 - 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 (Mumbai)
🏢 Job Proffer
📍 Mumbai

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