- B-3A-03, Konpleks Perindustrian EmHub, Persiaran Surian, Seksyen 3, Taman Sains Selangor, Kota Damansara, Petaling Jaya Selangor Malaysia 47810

Working Location
Job Description
Requirements
Education: Bachelor’s Degree in Pharmacy, Pharmaceutical Science, Chemistry, Food Science, Biotechnology, or a related scientific discipline.
Experience: Minimum of 3 years and above of progressive operational experience in regulatory affairs, managing multiple cross-functional categories (Cosmetic/Pharma/Device/Food).
Technical Mastery: Proven track record in compiling PIF directories, managing ISO documentation setups, and dealing directly with government license pipelines.
Competencies: Exceptional eye for detail, strong negotiation and communication capabilities with government agencies, and robust problem-solving skills under tight filing schedules.
Responsibilities
Product Registration & Compliance Portfolio
-Manage all submission, variation, registration, and renewal workflows for diverse product categories: Cosmetics, Pharmaceuticals, Medical Devices, and Food Products with national health authorities (e.g., NPRA / Ministry of Health).
- Author, review, and organize dossiers to ensure technical specifications match regulatory framework demands.
- Monitor changing food regulations, cosmetic directives, and pharmaceutical mandates to formulate proactive compliance strategies.
PIF Maintenance & Technical Dossiers
-Build, continually update, and maintain comprehensive Product Information Files (PIFs) for cosmetics and relevant compliance binders for other portfolios.
-Conduct meticulous reviews of raw material data sheets, safety assessments, product claims, and artwork labels to ensure alignment with marketing plans and strict regulatory frameworks.
ISO Standards & Quality Management
-Lead internal quality frameworks and sustain operational compliance for corporate quality milestones such as ISO 9001
-Act as a core coordinator during internal and external audits, handling formal communications and correcting discrepancies raised during inspections.
Business License Management
-Supervise the application, validation, and timely renewal of vital corporate documents, including wholesale licenses, manufacturing facility clearances, import/export certificates, and municipal Business Licens
Benefits
TAMAN JAYA
0.3 km
ASIA JAYA
1.1 km
UNIVERSITI
2.0 km
Important Information
Never provide your bank or credit card details when applying for jobs. Do not transfer any money or complete unrelated online surveys. If you see something suspicious, Report this Job ad.