1 Jobs for Pharmacist found

Job Description

- Has experience in filing and manage at least one new drug application until successfully obtained the approval as a project leader ‐ To handle regulatory activities (e.g. eCTD, GMP clearance, Import license renewal, etc.), life cycle management within good time and in compliance with company policies and local regulations.- To handle pharmacovigilance (PV) and quality assurance (QA) activities with stakeholders in compliance with local regulations, global and company policies.- To handle database management.- To provide recommendations and information related to regulatory, PV and QA to Sales and Marketing, affiliates, etc.- To establish effective relationship with Thai FDA and gain their trust and respect.- Experiences in PV and/QA function are plus.