Regulatory Affairs Coordinator

Role and Responsibilities

(Overall key responsibilities)

The Regulatory Affairs Coordinator manages administrative support activities and regulatory documentation to help ensure a smooth product registration process, including:

🔹 Core Responsibilities

• Coordinate with external laboratories, including government laboratories (TIRTR, DMSC, INMU, etc.), private laboratories (SGS, Central Lab, ALS, etc.), and overseas laboratories (CLF, Eurofins, MxNS) to support analytical testing.

• Prepare financial summaries (e.g., monthly F&A reports) and coordinate invoice/expense clearing for external parties, industry association membership (FTI, PNMA, etc.), external training agencies, e-claim clearing, and PRPO/GR processes for RA.

• Manage all registration documents as the document controller and distribute them to relevant stakeholders.

• Monitor and summarize updates from FDA and the Office of the Consumer Protection Board (OCPB), including competitor product registration information.

• Serve as the WISE coordinator.

• Maintain the GS online database (e.g., licenses to operate, regulatory updates, and internal policies).

• Provide administrative support for regulatory activities (e.g., product notification, registration, certification, and stationery/office support).
  

🌱 SN Essentials

All employees are accountable and responsible for:

• WISE2 — Being Healthy and Safe at work everywhere, every day

• iCare — Excelling in quality everywhere, every day, to deliver out promises

• Nature — Preserving & renewing our planet’s resources

• Compliance @ SN — Ensuring ethical business practices

⚙️ Main Duties and Functions

🧪 Lab Analysis

• Coordinate with external laboratories (government: TIRTR, DMSC, INMU, etc.; private: SGS, Central Lab, ALS, etc.; overseas: CLF, Eurofins, MxNS, etc.) to support the registration process.

🍏 Healthier Logo

• Prepare applications to submit to INMU for Healthier logo approval per business request and update license validity.

🗂️ Regulatory Database

• Update government FDA system databases and Healthier logo databases for relevant business categories.

• Monitor FDA and OCPB websites for news and new regulations/guidelines.

• Maintain a documentation system for licenses to operate (manufacturing, import, DLD, product licenses, Healthier logo, etc.).

• Ensure FDA licenses and approved labels are distributed to relevant functions (MKT, QFS, R&I, SC, Medical Nutrition, etc.) and are ready for internal and external audits.

🧾 Administration

• Manage regulatory expenses (internal: PRPO/GR, advances, e-claim, vendors; external: laboratories, training, industry association memberships, online stationery).

• Arrange meetings for weekly RA Thailand updates and quarterly SEA RA product reviews; support GS activities/events; and serve as the SPOC between RA and internal functions.

• Maintain laboratory reports and records for analysis and registration fee budgeting.
  
  

⚠️ Major Challenge of the Job

• Strictly check all registration documents and ensure they are completed in the system.

• Respond to urgent requests from internal stakeholders regarding registration documents, ensuring accuracy and timely action.

• Difficulty identifying the exact timing of the COA process for urgent cases due to uncontrollable factors such as testing results (not meeting R&D targets and requiring re-testing) and laboratory queue times.

📊 Expected Performance / KPIs

⏱️ Timeline

• COA coordination — achieve 100% of committed timeline

Data Management

• Document control & distribution: Maintain 100% version-controlled storage for assigned licenses/labels and distribute within 2 business days of approval/receipt.

• Data Correctness: Keep GS online database entries for assigned licenses/approvals up to date with ≥98% accuracy (≤2% errors found in audits).
  
  Working Relationships (Internal)

  • R&I

    • Coordinate to send sample and accuracy nutrition target to all external laboratories

    • Coordinate to distribute registered documents after FDA approval

  • Marketing

    • Coordinate to distribute registered documents after FDA approval

  • QFS

    • Coordinate to distribute registered documents after FDA approval for A/W development and Halal submission

  • SSD

    • Coordinate to distribute registered documents after FDA approval for Customs clearance and ITD submission

  • F&A

    • Coordinate with Financial & Accounting for all expenses of registration work, lab analysis, RA expense

  • Admin / Mailing

    • Coordinate document sending to MKT, Executive Secretary at ADRH

    • Coordinate for sample sending to CLF laboratories by DHL

    • Coordinate for document preparation and traveling (company car)

  • Secretary of management

    • Process for management signature for regulatory document

    • Follow up and ensure that all documents are signed and ready to be used
      
      

Working Relationships (External)

FDA & OCPB Officials

• Monitor daily news, announcements, and regulatory updates on official websites.

External Laboratories

• Submit samples and nutrition targets for analysis (COA).

• Control timelines for urgent COA requests.

• Resubmit samples for re-testing if results are out of specification.

External Vendors

• Create vendor

• Management of PRPO/GR and payment
  

Decision Making Authority and Controls

• Control the sample submission to all external laboratories and ensure that all sample code and target are accurate

• Control and negotiate with the external laboratory in terms of timing, re-testing, COA reporting, financial issues, etc

• Solve the problems that are from the external laboratory agencies issues and recommend team for the direction to achieve the target as plan

• Respond to internal stakeholder requirements for documents and related issues with confidence, using accurate information and a constructive approach

• Manage and make decisions for basic/routine work

Job Specifications

Education

• Bachelor degree of Science or any related fields

Must Have Technical / Functional Skills (Top 3)

• Able to communicate effectively in English

• Teamwork

• Service mind

Experience

• 1–2 years of experience providing administrative support

• Good relationship. Ability to work well with all levels of internal management and staff and external stakeholders

• Good attention in detail, sense of urgency and able to prioritize work to meet deadline

Computer Skills

• Microsoft Word, PowerPoint, Excel

• Photoshop

• VDO editor

• AI user

Others – Information Security

• To be familiar with and abide with the terms and conditions stated in the Non-Disclosure Agreement and Information Security Policy manual pertaining to the handling and protection of company’s information and equipment.

• Users of Internet resources should act responsibly and always maintain the confidentiality of corporate data and information.