Regulatory Affairs Specialist-API
BioconBengaluru, Karnataka, India7 days ago
Job description
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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Regulatory • Bengaluru, Karnataka, India
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