Regulatory Assistant

4 weeks ago

Vadodara, India Real Placement Full time

**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.

**Salary**: ₹240,000.00 - ₹360,000.00 per year

Schedule:

- Day shift

Ability to commute/relocate:

- Vadodara, Gujarat: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 1 year (preferred)

**Speak with the employer**
+91 7003440247

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