Vacancy For Officer Regulatory Affairs

1) Prepare and review new as well as Re-registration CTD and ACTD dossiers and handling queries for all Formulations

2) All FDA related applications and follow ups through Xln india, FDA-WHO GMP sites including Import permissions, Export NOC, and new FDC applications through CDSCO-Sugam Portal.

3) Co-ordinate with Quality Assurance dept. for preparation of documents which is required for FDA purpose (Inspections) as well as any registration process (Export countries regulatory agencies audits)

4) Responsible for preparing and biding local as well as export tenders

5) Trademark and Copyright registration records to be tracked and updated.