Degree in Chemistry / Microbiology or analytical chemistry discipline or relevant discipline.
Regulatory experience in Chemical industry
Understand Halal, Kosher requirement and application process
Familiar with REACH, FDA, GHS guidelines
Good document management skill and willing to spend more time on paper work
Experience with Asia Pacific regulatory processes and bodies
Detail-oriented and intrinsically motivated
Skilled user of Microsoft Office 365. knowledge on Intelligent Authoring will be a plus.
Accountabilities:
Issue regulation compliance letter to the customer promptly and accurately when required.
Providing product-related regulatory information and knowledge to the stakeholder to make sure 100% compliance.
Obtain regulation information from the supplier
Maintain and update the regulation database
Assess regulatory requirements and develop regulatory strategies for the qualifications of new products in ASEAN, Australia, and New Zealand.
Compile technical files, test reports and documentations necessary for regulatory submissions.
Maintain up to date documentation and archival regulatory submissions and related documents according to the company’s documentation policies and procedures.
Work with the global regulatory affairs group and manage areas of regulatory risk to core business activities in Asia.
Maintain up-to-date knowledge and information related to product regulation.
Understand the product registration requirement in Asia countries and manage the product registration when required.
Stay updated on industry regulations, policies, trends, and opportunities by participating in industry associations and conferences.
Generate product SDS and make sure the SDS is up to date to the regulation requirement.
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