Senior Regulatory Affairs Manager

Bangkok, Thailand

Job Type:

Full Time

Job Description:

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