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Regulatory Affairs / Quality Assurance Professional

Regulatory Affairs / Quality Assurance Professional

Enagic Malaysia Sdn BhdKuala Lumpur, Kuala Lumpur, Malaysia
17 hours ago
Job description

Regulatory Affairs / Quality Assurance Professional

Minimum : Bachelor’s degree in relevant fields

Preferred (senior roles) : MSc in Regulatory Affairs / Pharmaceutical Sciences / Public Health / Pharm.D / Ph.D.

Relevant disciplines include Life Sciences (Biology, Biochemistry, Microbiology), Pharmacy, Chemistry, Biomedical Science, medicine and nursing, Engineering (especially medical devices), or Law (for regulatory legal roles).

Skills & Knowledge

  • Knowledge of regulatory guidelines : FDA, EMA, NPRA (Malaysia), ICH, ISO, ASEAN
  • Understanding of :
  • Clinical trial processes
  • Product lifecycle
  • GMP / GDP / GCP
  • Strong documentation and submission skills (dossiers, variation applications, registration files)
  • Communication & negotiation with regulators
  • Attention to detail and project management

Experience

Entry-level : Fresh graduates with relevant degrees and internships / coursework in regulatory fields

Mid / Senior-level : 2–10+ years in Regulatory Affairs, QA, or Clinical

Malaysia-Specific Knowledge

Familiarity with NPRA, DCA, and MDA guidelines is highly preferred.

Additional Information

For your information, our company is currently engaging Pharmacosip Consultancy to support all external matters related to pharmaceuticals, food, and cosmetic products (e.g., registration, licensing, labelling compliance, advertising review, GDP documentation).

During Good Distribution Practice (GDP) audits conducted by the NPRA, it is generally required that an internal staff member (Responsible Person, RP) be present to :

  • Answer queries from NPRA inspectors
  • Provide access to SOPs, distribution records, temperature logs, recall procedures, etc.
  • Accompany inspectors during physical inspections of storage areas, vehicles, equipment
  • Demonstrate GDP implementation and explain compliance procedures
  • Rectify or explain non-conformities where possible
  • Hence, we are particularly looking for candidates who can take on this Responsible Person (RP) role and fulfil these obligations during audits.

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    Regulatory Assurance • Kuala Lumpur, Kuala Lumpur, Malaysia