Regulatory Affairs Specialist-API

3 weeks ago


Bengaluru Karnataka India, Karnataka 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


  • regulatory affairs

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