Regulatory Affairs / Quality Assurance Professional

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 :

Hence, we are particularly looking for candidates who can take on this Responsible Person (RP) role and fulfil these obligations during audits.

Be careful - Don’t provide your bank or credit card details when applying for jobs. Don't transfer any money or complete suspicious online surveys. If you see something suspicious, report this job ad.

#J-18808-Ljbffr