Regulatory Affairs Specialist-API
1 week ago
Role Summary /Key Responsibilities
- DMF compilation and submission to global markets
- Handling post approval submission and CIP assessments
- Submission of DMF amendment & response to Health Authority queries
- Providing customer support
- Evaluating change control assessment
- Providing Regulatory input for New molecule development activities
- Maintaining Regulatory data base
Qualification:
M.Sc./ M. Pharm
Exp: 10
years - 16 years
-
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