Kerja Sepenuh Masa Regulatory Affairs Officer- Executive, Gaji tinggi MYR 6,000 di Pevonia Malaysia Selangor - Maukerja

Key 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 License.

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.

Pay: RM4,000.00 - RM6,000.00 per month

Benefits:

• Health insurance
• Maternity leave
• Opportunities for promotion
• Parental leave
• Professional development

Work Location: In person