Following up and completing documents related to the Food and Drug Administration and updating and validating licenses and permits.
Direct communication with regional representatives for drug registration.
Reviewing and amending all proformas and invoices for foreign raw materials by ensuring their compliance with the rules of the Drug Administration and product manufacturing licenses.
Reviewing product batch records by ensuring their compliance with the regulations.
Documenting and archiving all relevant reports.
Requirements:
Ability to go on missions and business trips.
Familiarity with the requirements of ISO standards.
Familiarity with Pharmacopoeia standards.
Familiarity with regulatory affairs and the ability to write CTD.
Familiarity with the raw material production process.
Familiarity with quality assurance matters.
Proficient in obtaining drug distribution licenses based on the type and conditions of the drug.
