Regulatory Affairs Specialist

Description

• Providing support to regulatory related timely submissions and registration maintenance, other activities assigned as appropriate
• Responsible for dossier compilation to ensure ready to submit dossier is available as per local country requirements
• Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met.
• Monitor and manage product registration and life cycle management
• Ensure labelling compliance
• Support promotional material processes
• Ensure maintenance and update of regulatory files and records including appropriate archiving of all relevant documentation in appropriate systems in line with applicable internal company standards
• Liaise with Global/Regional RA and local Regulatory Authority to ensure full local regulatory and company compliance
• other duties as assigned.

Qualifications

• Bachelor’s Degree in Pharmacy (Pharmaceutical science).
• 5-7 year experiences in regulatory administration or documentation is preferable.
• Actively responsible and well-organized.
• Positive attitude and passion on regulatory work and document.
• Good communication and interpersonal skills.
• Outstanding skills in MS Word, MS Excel, Internet, E-mail, PDF, typing both Thai & English.
• Competency in problem solving and handle issues with Thai FDA and DLD
• Good command in English both written and spoken