Responsibilities:
Drive reduction of registration cycle time through Speed to Market initiatives.
Work closely with Global RA team to obtain complete registration documents for faster product registrations in Thailand.
Understand and influence Thailand regulatory environment by leveraging key relationships with industry groups.
Define and implement regulatory strategy and plan for Business Units in Thailand.
Assist Commercial team on product artworks and labelling compliance.
Provide leadership in interpretation. Provide support and advice to the parties involved (employees, customers, distributors, suppliers, etc.) to understand and follow the SOP in accordance with Corporate Quality Policy.
Provide training to Thailand employees in all RA related subjects.
Manage Pharmacovigilance, product complaints, non-compliant products and processes in collaboration with Global RA, Global QA, and commercial teams.
Manage people, budget and resources of Regulatory Affairs.
Focus on new product registration and paper work.
Qualifications:
Bachelor’s degree in Pharmacy
Must be familiar with Regulatory environment, and have an understanding of labeling regulations and controls
5-10 years’ experience in regulatory affairs and product registration management,
Must be able to interact with internal Client teams and manufacturing site personnel in a professional manner
Solid work experience with Multi-National Companies in Pharmaceutical experience