Regulatory Affairs Supervisor in Yangon

Regulatory Affairs Supervisor

DKSH ( Myanmar ) Ltd.

ရန်ကင်း | ရန်ကုန်တိုင်း

ရန်ကုန်တိုင်း

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Regulatory Affairs Supervisor

Regulatory Affairs Supervisor

DKSH ( Myanmar ) Ltd.

ရန်ကုန်တိုင်း

Regulatory Affairs Supervisor

DKSH ( Myanmar ) Ltd.

Myanmar - ရန်ကုန်တိုင်း

ရန်ကင်း | ရန်ကုန်တိုင်း

14 Sep 2020

လုပ္သက္အဆင့္

Experienced Non-Manager

အလုပ္အမ်ိဳးအစား

Quality Assurance

Job Industry

ဆေးဝါးနှင့် ဆေးဘက်ဆိုင်ရာသိပ္ပံ

အနိမ့္ဆံုး ပညာအရည္အခ်င္း

Bachelor Degree

Job Type

Full Time

လုပ္ေဆာင္ရမည့္တာ၀န္မ်ား

An Exciting Opportunity for ...

Support superior in managing day-to-day operating expenditures against operating budgets to ensure efficient usage of resources
Supervise and implement the regulatory affairs' policies, procedures and standards to ensure alignment to global DKSH quality policy and local/international quality standards
Prepare required product sample and documents for application of medical device licenses before importation.
Design quality management systems, include data management, quality criteria/checklists, supporting tools and techniques
Conduct investigations of non-conforming regulatory affairs activities, including identifying underlying causes, and suggesting corrective actions
Provide constructive recommendations to enhance policies, practices and processes related to quality assurance (QA), safety, health & environmental (SHE) and registration (REG)
Identify training needs - quality assurance (QA), safety, health & environment (SHE) and registration (REG) - and organize training interventions to meet quality standards
Coordinate quality development activities focusing on regulatory compliance such as audits, quality management reviews, and trainings
Provide technical assistance to internal stakeholders on regulatory affairs related issues, and trouble shooting when necessary
Liaise with internal and external stakeholders (i.e. government bodies) on regulatory affairs related queries, laws and regulations

Open To

Male/Female

လိုအပ္ေသာအရည္အခ်င္း

Diploma/certification of Science, Chemistry, Pharma or related disciplines
Minimum one years’ experience in regulatory field and coordination with FDA.
Demonstrate knowledge in quality assurance tools, concepts and methodologies
Demonstrate good knowledge in Dangerous Goods Regulations and Safety Data Sheets (SDS)
Demonstrate basic understanding of the Global Harmonized System (GHS)
Demonstrate good working knowledge, comprehension and applications of local regulations
Demonstrate proficiencies in office productivity tools (e.g. Excel, Word and PowerPoint)
Demonstrate appreciation and respect for cultural sensitivities especially in cross-country/-cultural interactions
Demonstrate fluency in local language and ideally in English, both written and spoken