Regulatory Affairs & Compliance Executive

ROLE PURPOSE

To secure and maintain market access for the Group's products by managing product registrations, regulatory documentation, packaging and label compliance, and liaison with authorities and regulatory consultants across Malaysia and export markets — with specific responsibility for ENDS / Fragrance products and consumer product lines.

KEY RESPONSIBILITIES

a. Product Registration

Own the end-to-end registration lifecycle for all assigned products so that every product is legally cleared for sale before launch and stays compliant throughout its market life.

▪    Plan and prepare new product registrations, renewals, variations and amendments according to the product launch calendar and regulatory timelines.

▪    Submit and manage applications through local and export regulatory portals, including NPRA QUEST3+ (cosmetic notification), SIRIM, ESMA (UAE) and other market-specific systems.

▪    Determine the correct regulatory category and requirements for each product and market before submission.

▪    Track application status, respond to authority queries and deficiency letters, and resubmit promptly to avoid approval delays.

▪    Coordinate registration fees, payments and official approval documents with Finance and relevant teams.

▪    Ensure at least 95% of submissions are made on time and highlight any risk to launch dates early to management.

b. Regulatory Documentation

Build and maintain complete, accurate and audit-ready regulatory dossiers for every product.

▪    Compile and verify technical documents including Safety Data Sheets (SDS), Certificates of Analysis (COA), full ingredient lists / formulations, stability and test reports, declarations, GMP and origin certificates.

▪    Obtain missing or updated documents from suppliers, manufacturers (including the Tampin plant and overseas suppliers) and accredited laboratories.

▪    Check each document for consistency across formula, label claims and test results before it is submitted.

▪    Review document requests from internal teams, customers and distributors and respond within 2 working days.

▪    Maintain a structured, version-controlled document library so any file can be retrieved quickly during audits or authority inspections.

c. Packaging & Label Compliance

Ensure no packaging, label or marketing claim goes to production or market without regulatory clearance.

▪    Review all packaging artwork, labels, inserts and product claims against country-specific rules (e.g. mandatory information, language, warnings, health warnings for ENDS, ingredient nomenclature, batch and expiry formats).

▪    Give clear written feedback and required corrections to the Design, Marketing and Product teams, and sign off final artwork before release.

▪    Review marketing and e-commerce claims for regulatory risk where applicable.

▪    Keep a record of approved artwork versions and ensure 100% of artwork is reviewed before production.

d. Authority & Consultant Liaison

Serve as the Group's day-to-day point of contact with regulators and external regulatory partners.

▪    Handle regulatory enquiries, clarifications and meetings with authorities such as the Ministry of Health / NPRA, SIRIM and overseas regulators.

▪    Appoint, brief and manage external regulatory consultants and in-country agents for export markets, and monitor their deliverables and timelines.

▪    Log every enquiry and case, follow up consistently and keep stakeholders informed until the case is fully closed.

▪    Build and maintain professional working relationships with regulators, testing labs and consultants.

e. Licence & Certification Register

Keep the Group's licences and certifications valid at all times so that no product or entity operates with an expired approval.

▪    Maintain the master register of product registrations, business and import / export licences, permits and certifications, including issue and expiry dates and responsible owners.

▪    Update the register monthly and send renewal reminders well ahead of expiry (e.g. 90 / 60 / 30 days).

▪    Coordinate renewal submissions and supporting documents with the relevant entity and department.

▪    Report upcoming expiries and any lapses to management immediately.

▪    Regulatory Intelligence

▪    Anticipate regulatory change so the business can adapt before it becomes a compliance issue.

▪    Monitor new and amended laws, guidelines and standards in Malaysia and the Group's export markets (including Act 852, cosmetic regulations, GCC and ASEAN requirements).

▪    Assess the impact of each change on existing products, packaging, formulations and launches.

▪    Issue a regulatory update with an implementation plan and deadlines to affected departments within 5 working days of a significant change.

▪    Follow up to confirm that required changes have been implemented by each team.

f. ENDS Market Access

Secure and protect market access for the Group's vape / ENDS portfolio.

▪    Apply local and international ENDS requirements, including Malaysia's Control of Smoking Products for Public Health Act 2024 (Act 852), EU TPD and US FDA PMTA frameworks, to every vape product.

▪    Coordinate product notifications, emissions and ingredient testing, device and battery certification, and technical file preparation required for each market.

▪    Work with manufacturers (including suppliers in Shenzhen) to obtain the technical data and test evidence needed for approval.

▪    Advise the Commercial and Product teams on which markets and product formats are feasible, and the timeline and requirements for entry.

▪    Maintain market access by managing renewals, post-market reporting and any changes to approved products.

g. Cross-functional Quality

Make regulatory compliance part of product development and manufacturing, not an afterthought.

▪    Work with QA/QC, R&D and manufacturing teams to align specifications, testing and batch documentation with regulatory requirements.

▪    Review new product briefs, formulations and supplier changes early and flag regulatory requirements or restrictions.

▪    Support investigations of non-conformances, complaints, product recalls or authority findings, and help drive corrective actions.

▪    Support internal and external audits by providing regulatory records and evidence.

h. Tracking & Reporting

Give management full, real-time visibility of the Group's regulatory status.

▪    Keep the regulatory tracker updated for all submissions, approvals, renewals, open cases and deadlines.

▪    Prepare and submit a monthly regulatory status report to stakeholders covering progress, risks, delays and upcoming expiries.

▪    Use regulatory and project systems (e.g. Arcus on Atlassian Jira and regulatory portals) to improve tracking, document management and process efficiency.

▪    Recommend and implement process improvements, templates and SOPs to shorten registration lead times.

QUALIFICATIONS & EXPERIENCE

Minimum

▪    Bachelor's Degree in Chemistry, Pharmacy, Chemical Engineering, Biotechnology, Industrial Chemistry, Food Science or a related science discipline.

▪    2 – 4 years' experience in regulatory affairs or product compliance for consumer products (cosmetics, FMCG, fragrance, ENDS/vape, pharmaceuticals or medical devices).

▪    Hands-on experience with regulatory submissions and portals, preferably NPRA QUEST3+ and/or SIRIM.

▪    Able to read and assess technical documents: SDS, COA, test reports, ingredient declarations.

▪    Strong written and spoken English and Bahasa Malaysia.

Preferred

▪    Working knowledge of ENDS / tobacco-product regulation — Malaysia's Control of Smoking Products for Public Health Act 2024 (Act 852), EU TPD, US FDA PMTA.

▪    Export-market registration exposure, especially GCC (ESMA / UAE) and ASEAN.

▪    Packaging and labelling compliance experience across multiple countries.

▪    Familiarity with Jira or similar tracking tools; Mandarin is an advantage for liaison with China-based suppliers.