Assistant Regulatory Officer - Pharma

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.