Regulatory Affairs Officer

5 months ago


Vadodara Gujarat, India Afrinext overseas pvt. Ltd. Full time

Ø Preparation, Compilation and review of registration dossier of tablet /capsule/injection in CTD, ACTD as well as country specific format for countries

Ø 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 COPP (Certificate of a Pharmaceutical Product).

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.

Ø Preparation and handling of NOC for exports countries.

**Salary**: ₹25,000.00 - ₹30,000.00 per month

**Benefits**:

- Health insurance
- Provident Fund

Schedule:

- Day shift

**Experience**:

- total work: 1 year (preferred)

**Speak with the employer**
+91 9974970676



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