Regulatory Chemist Specialist

2 Years ago • All levels • Legal

Job Summary

Job Description

The Regulatory Chemist Specialist (RAS) is responsible for preparing and filing regulatory approval demands for company products. This includes coordinating, supervising regulatory submissions, and reviewing product conformance to ensure compliance. The role involves implementing strategies to meet evolving regulatory initiatives, registering products according to provincial guidelines and third-party supplier regulations, and staying current with regulations. The specialist will also participate in conferences and interdepartmental meetings, ensuring product-related regulatory information and knowledge are provided to stakeholders for 100% compliance.
Must have:
  • Degree in Chemistry/Microbiology/analytical chemistry
  • Regulatory experience in Chemical industry
  • Understand Halal, Kosher requirement & application
  • Familiar with REACH, FDA, GHS guidelines
  • Good document management skill
  • Detail-oriented and motivated
  • Skilled in Microsoft Office 365
Good to have:
  • Experience with Asia Pacific regulatory processes
  • Knowledge on Intelligent Authoring

Job Details

Description

 is to prepare and file demands for regulatory approval of the products of the company by preparing, coordinating, and supervising regulatory submissions and reviewing product conformance and assure compliance, Implementing different strategies in order to meet evolving regulatory initiatives, register products according to provincial guidelines and regulations of third party suppliers Keep current with regulations Participate in conferences and interdepartmental meetings.

 

Qualifications & Experience: 

      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.

 #LI-SS1

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