Assistant Regulatory Officer

2 days ago


Vadodara, Gujarat, India Actide International Full time ₹ 4,00,000 - ₹ 6,00,000 per year


Job Description:

Job responsibilities :

  • Preparation, Compilation and review of registration dossier of tablet /capsule/injection in CTD,
  • ACTD as well as country specific format for countries
  • Preparation, Compilation and review of registration dossier of capsule/syrup/balm in a Herbal
  • products for country specific format in countries of African Region, Cambodia, Myanmar, CIS
  • To manage new registration / preregistration / query response / variation filling for abroad markets
  • (AFRICAN, ASIAN & CIS REGIONS).
  • Preparation and review of COPP (Certificate of a Pharmaceutical Product).
  • Preparation and review of FSC (Free Sale Certificates)
  • Preparation, compilation and submission of variants.
  • Responsible for drafting of query response for assist countries received from MOH & Consultant.
  • Preparation of product permission for both of export products.
  • Coordination with various department of manufacturing as per the requirement of documents for
  • dossier compilation and do follow up of finished product for sampling purpose.
  • Preparation and handling of NOC for exports countries.



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