Executive Regulatory Affairs | Global Calcium | Chennai, Bangalore

Job Description

  • Preparation and review of the dossiers as per the current prescribed guidelines of the respective regulatory authorities
  • Having Knowledge of Common Technical Document (CTD) and Electronic Common Technical Document (eCTD) dossiers format for Regulatory Submissions
  • Preparing, reviewing, and submitting ANDA as per guidelines for Regulated and Non-regulated markets
  • Preparing, reviewing, and submitting Drug Substance dossier for approval of Certificate of Suitability (COS) by EDQM through eCTD and NeeS format.
  • Preparing, reviewing, and submitting the open part ASMF/EDMF to customers.
  • Preparing responses and providing declarations based on the customers and Regulatory queries.
  • Preparation of dossier which addresses the responses to deficiencies received from various regulatory authorities (EDQM/USFDA etc)
  • Preparation of CMC dossiers for regulatory and semi-regulatory markets (LATAM, ASEAN, and the Middle East) to obtain high-quality CMC documentation.
  • To update the Regulatory Affairs records on a routine basis and maintain database management.
  • Timely preparing, submitting, follow-up of Regulatory applications, and maintaining product database to Regulatory Authorities.
  • Reviewing the documents like AMV (Analytical Method Validation), Process validation, and Stability data reports for accurate, efficient, and updated compilation of the dossiers.
  • Having Knowledge of eCTD Software for electronic submissions.
  • Coordination with various departments includes QA, R&D, and Packing for regulatory requirements for dossier submission and approvals.
  • Handling technical/administrative queries related to regulatory submission and responding to them on time.
  • Preparation of technical documents requirements for a Product manufacturing license, Product GMP, Plant License, Certificate of pharmaceutical products, NOC, and Test License is added advantage.
Qualification: MS/M.Sc(Science) in Chemistry, M.Pharma