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Regulatory Manager-Pharma
2 months ago
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.
Experience level: 5- 6 years in Pharma (preferred in Working with merchant exported)
Salary: 35- 45 thousand per Month ( Negotiated if candidate is good)
Key Skills :
Regulatory Affair Drug Regulatory Affair Copp