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Assistant Regulatory Officer - Vadodara, India - Actide International

Actide International

Verified Company

Vadodara, India

1 month ago

Posted by:

Deepika Kaur

beBee Recuiter

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
Experience level: 23 years in Pharma (preferred in Working with merchant exported)

Job Types:
Full-time, Commission

Salary:
₹200, ₹300,000.00 per year

Ability to commute/relocate: