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Regulatory Affairs Specialist-Api

Regulatory Affairs Specialist-Api

BioconBengaluru, Republic Of India, IN
14 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, Republic Of India, IN

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