Sr. Officer To r

6 days ago


Ahmedabad, Gujarat, India Dishman Carbogen Amcis Full time US$ 40,000 - US$ 80,000 per year

Role & responsibilities

  • Preparation of DMF / ASMF / CEP dossiers as per the ICH M4 CTD/eCTD guidelines.
  • Response preparation as per the query
  • Preparation of renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations
  • Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authorities requirements
  • Coordination with various departments to collect the necessary information required for preparation of the CTD / ACTD / Country specific dossier.
  • Assist in preparation of dossier as per country specific requirement.
  • Any other job assigned by immediate supervisor/HOD

Preferred candidate profile

  • Hiring for API & Formulation background candidates for Regulatory Affairs Team
  • Good Communication Skill in English

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