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  • Regulatory Affairs Manager / Executive (Pharmaceuticals) Hanoi
  • PERSOLKELLY in Hanoi, , Vietnam
  • jobs
  • 6 days ago

jobs description

ROLES AND RESPONSIBILITIES
• Report to Regulatory Affairs Lead in Headquarter
• Develop regulatory strategies and implementation plans for the preparation and submission of new products.
• Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
• Advising and providing mandatory information related to the import of goods into the VN market.
• Follow up and resolve issues related to delivered products. Take necessary actions (submit renewal, change) to ensure products can be circulated continuously.
• Being the contact point for colleagues within the company in terms of all questions concerning the technical documentation and the approval of pharmaceuticals products and nutritional supplements.
• Process all the new dossiers till submit to DAV within the timeline.
• Liaise and negotiate with regulatory authorities.
• Keep up to date with changes in regulatory legislation to ensure compliance of the company.
•... Follow up and resolve issues related to delivered products. Take necessary actions (submit renewal, change) to ensure products can be circulated continuously.

REQUIREMENT
• Having experience in Pharma Regulatory Affairs with the same level
• Fluent English skills: Communication, Reading, Writing and Translation.

BENEFITS
• Salary Negotiable (Based on your experience) and Allowance.
• Opportunity to work in a professional and responsible environment.
• Other benefits of the Company such as training, working equipment.
• To participate in Social insurance, Health insurance and Unemployment insurance according to regulations.
• Full benefits as prescribed by Vietnamese Labor Law
Hanoi Vietnam

salary-criteria

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