Regulatory Affairs Specialist-API

1 week ago


Bengaluru, Karnataka, India Biocon Full time

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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