Officer / Executive - Regulatory Affairs

Location

Vadodara | India

Job description

• Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority.

• Well versed with the guidelines of ICH and other regulatory.

• Preparation of documents for license application.

• Preparation of documents for COPP, FSC and other legal documents including product permission

• Preparation of registration documents as per ACTD , CTD , country format / Review / Preparation & Compilation

• Preparation of text matter and checking of artworks.

• Should coordinate with factory for samples, working standards, document data, license related documents.

• Should have knowledge with regard to checking of samples.

• Courier of documents and samples to the respective customer.

• Maintaining status and record of dossiers, samples legal documents.

RA,Regulatory Affairs

Designation: Officer / Executive - Regulatory Affairs

Vacancies: 1

Experience: 2.0 Year(s) - 10.0 Year(s)

Job tags

Salary

Rs 2 - 5 lakhs p.a.