Regulatory Affairs

1 month ago


india Encube Ethicals Full time

Key Deliverables

  • Dossier compilation of initial MAA for Europe Market
  • Response to EU authorities deficiency
  • Scientific Advice
  • Variations and Supplements (Type IA, IA, Type IB Type
  • Timely review of technical and regulatory documents i.e. Specifications, batch records, method validation documents, Stability data, container closure system, DMF review.
  • Hands on Electronic Operation (eCTD)
  • E Submission Gateway
  • Behavioral Aspects



Skill Requirements

  • Min 5 years experience in Europe submission via DCP/MRP or National
  • Experience in addressing the EU authority deficiencies satisfactorily
  • Understanding and knowledge about presentation of data in Scientific advise from EU Agencies such as BfArM
  • Thorough knowledge of EU Variations in EU
  • Knowledge of the review of CMC/Clinical/Regulatory documentation required for submission
  • Working capabilitles preferably on PharmaReady or equivalent software
  • Working capabilities on CESP Portal preferred
  • Positive Attitude and Approach. Learning Abilities


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