Job Description
Senior Regulatory Manager at a Well-Known Health Care & Pharmaceutical Company in Yangon
Responsible for that the organization is attached to applicable regulations
Up to 2,000,000 MMK plus other benefits
About the Company
Our client is a leading Health Care Service Provider in Myanmar offering variety of products and services relating to healthcare products.
The Role
Manage the overall process of regulatory matters and requirements
Liaising and negotiating with regulatory authorities
Preparing documentations and contact with principal for renewal registration, etc.
Dealing with FDA / TMO / MPMEEA / for DIAC, sales & warehouse license
Provide strategic regulatory expertise and guidance for the development and review of technical protocols and reports (e.g. assay development, validation, stability, product development
Provide regulatory direction to address inspectional findings and support CAPA projects as applicable
Report directly to Principals / Business Head and develop company policies
Requirements
Minimum 3 years of managing experiences in regulatory fields
Bachelor’s degree is a must and allied to pharmacy or medicine is preferable
Strong command of English is required
Well discussion with government department, excellent management skills, QA / ISO training and Pharmacovigilance project are needed
Benefits
Annual Bonus and other allowances
Highlights
A rapidly growing organization which will allow your future to grow simultaneously with them
Career Growth Opportunities
Together with the growth of company business, there are a lot of potential for career development of the employees