Assistant Regulatory Officer

4 days ago


Vadodara, India Actide international Full time

Job responsibilities 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 / 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.
- Education: B. Pharm / M. Pharm

**Salary**: ₹200,000.00 - ₹300,000.00 per year

Schedule:

- Day shift

Ability to commute/relocate:

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

**Experience**:

- Regulatory reporting: 1 year (preferred)

**Speak with the employer**
+91 9328903544



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