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Regulatory Affairs Supervisor

DKSH ( Myanmar ) Ltd.
Recruiter active 21 hours ago The recruiter at this company was last active reviewing applications.
Myanmar - Yangon
Full Time
Verified This job has been verified by the company as a real job vacancy.
1 week ago

Experience level

Experienced Non-Manager

Job Function

Quality Assurance

Min Education Level

Bachelor Degree

Job Description

  • 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

Job Requirements

  • 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

What We Can Offer

Benefits

Rewards for over performance

Highlights

International Standards

Career Opportunities

Learn new skills on job

About Our Company

DKSH is the leading Market Expansion Services provider with a focus on Asia. The Group helps other companies and brands to grow in the Consumer Goods, Healthcare, Performance Materials and Technology sectors. DKSH’s portfolio of services includes sourcing, market insights, marketing and sales, distribution and logistics as well as after-sales services. Publicly listed on the SIX Swiss Exchange, the Group operates in 35 markets with 33,000 specialists, generating net sales of CHF 11.3 billion in 2018. With its strong Swiss heritage and long business tradition since 1865, DKSH is deeply rooted in Asia Pacific.

DKSH’s strength lies in our great diversity of services, industries, clients, products, regions and employees from various nationalities. We are proud of our people: they are the reason we are successful. Our people are the best in the industry. They are passionate about their career growth and about business success. They work as part of an energetic and committed team, positively impacting millions of lives through the products and services we provide. Join us today if you are ready to “Drive growth. Be the Difference.” With DKSH, you will experience a world of learning and development, own your career and take business responsibility and have a positive impact that touches people’s lives.

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Experience level

Experienced Non-Manager

Job Function

Quality Assurance

Min Education Level

Bachelor Degree

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