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Regulatory Affairs Executive (RA Executive)

Job Summary

To ensure to get approval in time. To be a smooth business flow, do regular checking and maintain the approval validity of every product codes of assigned principal.

  • Minimum Qualification: Bachelor
  • Experience Level: Mid level
  • Experience Length: 1 year

Job Description/Requirements


·         Responsible for preparation and submission of all documents and other required needs to Local Health Authority (Myanmar FDA) to get import recommendation approval of Medical Devices.

·         Also maintaining the relationship with suppliers (Clients) to get the required documents and other needs and also with internal teams/departments for smooth operation of RA procedures.

·         Keep update with FDA new announcements/ changes in regulatory laws & guidelines and share information to internal team and principal side if required.

·         Send regular report to principal side as required

·         Enable to handle advance/expense claim process with Finance team for departments’ expense. (if needed).

Requirements

·         Prefer Bachelor of Pharmacy

·         Master/Bachelor in Scientific

·         At least one to two-year experiences in regulatory affairs field

·         Strong negotiation, communication, organization, problem solving, team work and time management skills

·         IT skills

·         Good in English 4 skills

·         Good knowledge in regulatory regulations and guidelines

·         Background knowledge in regulatory practice and regulation of ASEAN and other countries

·         Experience in medical equipment, healthcare products and pharmaceutical products industry

·         Experience in working with government authorities

·         Ability to multitask and under limited supervision

·         Ability to travel if required

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Yangon
| Full Time |
MMK 800,000 - 1,000,000
6d