Regulatory Affairs Assistant in Yangon

Regulatory Affairs Assistant

DKSH ( Myanmar ) Ltd.

| Yangon

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Regulatory Affairs Assistant

Regulatory Affairs Assistant

DKSH ( Myanmar ) Ltd.

Regulatory Affairs Assistant

DKSH ( Myanmar ) Ltd.

Myanmar - Yangon

| Yangon

11 Feb 2021

Experience level

Experienced Non-Manager

Job Function

Quality Assurance

Job Industry

Pharmaceutical/Life Sciences

Min Education Level

Bachelor Degree

Job Type

Full Time

Job Description

A Big Opportunity for ...

Support manager in managing day-to-day operating expenditures against operating budgets to ensure efficient usage of resources
Support the implementation of regulatory affairs' policies, procedures and standards to ensure alignment to global DKSH quality policy and local/international quality standards
Prepare and assist in designing quality assurance systems, including the development of quality checklists, supporting tools and techniques
Identify, document and report on non-conforming regulatory affairs activities across the country
Analyze data to identify areas for improvement in the practices and processes related to quality assurance (QA), safety, health & environmental (SHE) and registration (REG)
Prepare training materials for quality management training - quality assurance (QA), safety, health & environment (SHE) and registration (REG) - to enhance employees' awareness of quality
Assist in any 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

Job Requirements

Diploma/certification of Science, Chemistry, Pharma or related disciplines (B.Pharm is preferable)
Preferred to have related work experiences
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 in English, both written and spoken
Able to travel at any time