6 Opening(s)
3.0 Year(s) To 10.0 Year(s)
5.00 LPA TO 7.00 LPA
DMF API Submission experience is must
Preparation of New Drug Master Files as well as DMF amendments for Brazil, US, and ROW market according to respective agencies requirements.
Preparation of Applicant part of DMF for Brazil, US, and ROW market.
Preparation of all administrative statements for respective authority requirements.
Drafting of regulatory response for ...
4 Opening(s)
1.0 Year(s) To 5.0 Year(s)
2.00 LPA TO 4.00 LPA
COA/ Certificate of Analysis
MSDS
Specifications/ TDS
Method of Analysis
Stability Data
DMF/ Drug Master File
Declarations
Preparation of Vendor Questionnaire
Customer response for technical queries
Must have knowledge of Pharmacopoeias, ICH guidelines
COA/ Certificate of Analysis
MSDS
Specifications/ TDS
Method of Analysis
Stability Data
DMF/ Drug Master File
Declarations
Preparation of Vendor Questionnaire
Customer response for technical queries
Must have knowledge of Pharmacopoeias, ICH guidelines,
1 Opening(s)
3.0 Year(s) To 8.0 Year(s)
3.00 LPA TO 6.00 LPA
Role & responsibilities
Design, finalize and propose specification of KSM, Intermediates and finish API as per developed control strategy.
Prepare the documents for Process development report and technology transfer.
Develop cost effective, high quality and minimum environmental hazardous process considering ICH guideline.
Finalize the route of synthesis after doing feasibility study of ROS to ...