Officer - Regulatory Affairs - Vadodara, Gujarat, India - Afrinext overseas pvt. Ltd.
Description
Ø Preparation, Compilation and review of registration dossier of tablet /capsule/injection in CTD, ACTD as well as country specific format for countriesØ 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
Ø To manage new registration / reregistration / query response / variation filling for abroad markets (AFRICAN, ASIAN & CIS REGIONS).
Ø Preparation and review of FSC (Free Sale Certificates)
Ø Preparation, compilation and submission of variants.
Ø Responsible for drafting of query response for assist countries received from MOH & Consultant.
Ø Preparation of product permission for both of export products.
Ø 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.
Schedule:
- Day shift
Ability to commute/relocate:
- Vadodara, Gujarat: Reliably commute or planning to relocate before starting work (required)
Experience:
- total work (preferred)
Speak with the employer
Application Deadline: 30/03/2023
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