Regulatory Associate

3 weeks ago


Cochin, Kerala, India Silmed Scientific Full time

We are hiring an experienced medical writer with experience in CTD medical writing and experience in clinical development of medicines.


Responsibilities:

  • Writing high quality CTD modules nonclinical and clinical overviews & summaries (Module 2.5, 2.4, 2.7, 2.7) as per requirements in EU submission
  • Response to clinical deficiencies
  • Assist with drug development strategy
  • SmPC, Patient information leaflet, CCDS updates, Safety variations
  • Clinical study reports, Study design and synopsis
  • Assist in clinical development strategy Review of Study reports published papers
  • Literature search and regulatory evaluation
  • Rx to OTC evaluation
  • PSURs, PADER, RMP

Requirements:

  • MBBS in Medicine/ M.Pharma in Pharmacy/ Medical-MS/MD in Pharmacology/ Ph.
D/Doctorate in Pharmacy

  • Experience in Medical writing for regulatory submissions in Europe.
  • Nonclinicaloverview / Clinical overview / PSUR / EU submission / ClinicalPharmacology / module 2.5 /Scientific Writing ICH / Regulatory Submissions / Medicine / DCP / CTD / Clinical Research / medical writer / Medical Writing / EMA labelling Module
  • Scientific accuracy
  • Attention to details
  • Experience in Clinical study design and protocol
  • Excellent communication skills and time management
  • Specialization in Pharmacology desired.

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