Chuyên viên Pháp chế (Regulatory Affairs Executive)

GENERAL DUTIES AND RESPONSIBILITIES
1. To be responsible for implementing and maintaining compliance with relevant regulations
and statutory requirements at all times, including chemicals, medical device, and other
applicable regulatory requirements, international standards, local regulations, codes of
practice, and legal requirements.
SPECIFIC DUTIES AND RESPONSIBILITIES
1. To achieve timely and efficient registration, declaration, licensing, and approval of Company
products (including chemicals, medical devices, and other regulated products), with regular
status reporting.
2. To facilitate product registration, licensing, import permit applications, and other regulatory
approval processes in accordance with applicable local regulations and quality system
requirements.
3. To ensure renewal of product registration, line extension, and any changes of registered
particulars are achieved in a timely manner with continual updates.
4. To collaborate with relevant divisions to ensure all imported and locally distributed products
remain compliant with applicable regulatory requirements throughout their lifecycle.
5. To maintain necessary record-keeping on regulatory related issues.
6. To liaise with regulatory authorities, auditors, certification bodies, and other external
stakeholders as and when required.
7. To provide supporting documents for all tender applications when necessary.
8. To advise, review, coordinate, and undertake all incidental matters to ensure the Company is
in compliance with the conditions of all licenses and relevant laws, regulations, notifications,
determinations, industry codes, guidelines and policy matters.
9. To ensure implementation of directives / notices from Government across the Company.
10. To support all licensing activities required by the Company's operations, to ensure that the
Company possess valid operating licenses / permits and to maintain ongoing compliance
with existing regulatory legislations.
11. To advise and update Management on government policies, affairs and requirements.
12. To perform any other work as and when required.