Regulatory Affair Manager

2 weeks ago

Pusat Bandar Puchong Selangor, Malaysia The Origin Foods Sdn Bhd Full time 90,000 - 120,000 per year

JOB DESCRIPTION


• Represent or lead the Regulatory Affair function on assigned cross-functional project teams.


• Develop, support and execute and maintenance of regulatory plans for Traditional and Health Supplement Product registrations, variations, renewal, amendment, audit.


• Support and co-ordination of regulatory related submission and audit to respective local health authorities (including NPRA, MOH, JAKIM, JAIS).


• To provide product-related regulatory guidance to relevant stakeholders and to navigate safely through regulatory hurdles in product and label registration with maximum interest for business while in compliance to local food laws and regulations.


• Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.


• Support local system in reference to local regulatory requirements and international guideline (eg CODEX).


• Assist with maintenance and preparation of local management system (SOPs) and internal audit in compliance to local regulatory requirements.


• Ensure project teams and business objectives and deliverables are aligned with regulatory strategy.


• To keep abreast of international legislation, guidelines and customer practices especially in countries that has local offices.


• Provide regulatory guidance and scientific support to R&D and Marketing.


• To oversee Halal management system and ensure Halal compliance. Support HALAL product registration and audit.


• To oversee Food related tasks eg label screening, Health certificate and Free Sales certification application.


• To oversee Food Classification application with NPRA.


• To apply for General Administration of Customs China (GACC) for products exporting to China.

JOB REQUIREMENT

  • Possess at least a Bachelor degree/ Diploma in science (e.g Bioscience Engineering/ Science / Food Science/ Biology / Chemistry / Pharmacology or medical related study)
  • Min 5 years of experience in handling Regulatory Affairs duties for Biotechnology, Nutrition/F&B/FMCG products regulatory compliance/affairs and Possess knowledge in Good Manufacturing Practice (GMP), Hazard Analysis Critical Control Point (HACCP).
  • Excellent communication skills both verbal and written in Mandarin preferred as the role requires the candidate to communicate with Mandarin speaking customer/ supplier.
  • Strong attention to the details and organizational skills as demonstrated by the ability to complete work on time with minimal errors.
  • Possess good problem solving, communication, planning and analytical skills to adapt to dynamic environmental changes.

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