Location
Vadodara | India
Job description
Job responsivities are to assist Regulatory manager
- 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 / reregistration / 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.
M Pharma,B pharma
Designation: Regulatory Assistant
Vacancies: 3
Experience: 2.0 Year(s) - 3.0 Year(s)
Job tags
Salary
Rs 2.4 - 3 lakhs p.a.
