Assistant Regulatory Officer - Pharma
1 Nos.
55479
Full Time
2.0 Year(s) To 3.0 Year(s)
2.00 LPA TO 3.00 LPA
Pharma / Biotech / Healthcare / Medical / R&D
Pharma/Biotech/Clinical Research
B.Pharma - Pharmacy; M.Pharma - Pharmacy
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.
Company Profile
Our client is multi-product export company specializing in a variety of wide range products like pharma, Chemical, medical Device & Surgical Products
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