Regulatory Affair Manager
- RGF Executive Search , Ho Chi Minh - Vietnam
- Competitive
- Posted: 09 Jan 2018
Job Description
- HCMC based
- OTC & ETC products
- Territory: Vietnam, Lao, Cambodia
YOUR EMPLOYER
- Our client. a French well-established healthcare group that represents more than 20 European pharmaceutical multinational companies is currently looking for a Regulatory Affairs Manager. They offer tailor-made services to their pharmaceutical clients to help them registering and promoting their products in Vietnam, Laos and Cambodia
YOUR RESPONSIBILITIES
- All registry activities related to MOH for company & product
- Prepare the quota dossier for non-registered drug & special drug for hospitals demand
- Registration of Company's products
- Prepare documents for asking MOH’s authorization
- Prepare the VN pakaging for registration & importation
- Prepare PIL for quota & registered products
- Support & step up activities relating to hospital quota products
- Relationship with MOH, SOH, DAV, Analysis Institute
- Follow up & perform all changes relating to registered drugs to MOH
- Management of staffs under responsibility for resolution of all matters relative to registration
- Provide basic training about policies & procedures
OTHERS
- Registry & Follow advertising or event dossier
- Prepare the notice for non-registered drug
- Follow up hospital quota approval
- Follow up trade mark protecting process, perform trademark search and advertising activities
Job Requirements
KEY REQUIREMENTS
- Bachelor's degree in Pharmacy or Medicine is a MUST
- Minimum 5 years of experience as the same position
- Fluent in English & Vietnamese (both written and spoken)
- Open and independent mind and attitude, a good listener and team player
Additional Information
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Job LevelManager
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SalaryCompetitive
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Function
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Location
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Job TypeFull-Time Permanent
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Posted09 Jan 2018