Regulatory Affairs Specialist-API
BioconBengaluru, India12 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, India
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