Kerja Sepenuh Masa REGULATORY AFFAIRS PHARMACIST, Gaji tinggi MYR 5,500 di Ecopeneer Selangor - Maukerja

Regulatory Affairs & Product Registration

• Support preparation and coordination of regulatory submissions for healthcare and diagnostic products.
• Assist in compiling and reviewing product registration dossiers and supporting documentation.
• Liaise with relevant authorities including Medical Device Authority and National Pharmaceutical Regulatory Agency on regulatory matters.
• Monitor regulatory requirements, updates, and submission timelines.
• Coordinate documentation and information required for product registrations, renewals, variation submissions, and regulatory maintenance activities.
• Support establishment license, regulated import, and related compliance activities.

Regulatory Compliance & Coordination

• Support regulatory compliance activities for regulated healthcare products and imports.
• Assist in maintaining regulatory records, licenses, permits, and documentation.
• Coordinate with internal teams, principals, suppliers, and external consultants on regulatory-related matters.
• Participate in internal compliance preparation and documentation activities.
• Support implementation and maintenance of SOPs and regulatory documentation processes.

Authority & External Liaison

• Act as liaison with government authorities and external stakeholders for regulatory and compliance-related matters.
• Coordinate with logistics agents, customs brokers, and suppliers regarding regulatory documentation and import requirements.
• Attend occasional meetings with authorities, principals, or external partners when required.

Cross-Functional Support

• Work closely with management on regulatory planning and market access activities.
• Provide internal regulatory guidance and support to commercial and operational teams.
• Support continuous improvement initiatives related to regulatory operations and documentation workflows.

Requirements

• Bachelor’s Degree in Pharmacy or equivalent qualification recognized in Malaysia.
• Registered pharmacist with valid APC preferred.
• 1–3 years working experience preferred; fresh candidates with strong interest in regulatory affairs are encouraged to apply.
• Experience in community pharmacy, hospital pharmacy, regulatory affairs, healthcare, diagnostics, or biotechnology industry will be an added advantage.
• Good understanding or interest in healthcare regulatory environment in Malaysia.
• Strong documentation, coordination, and communication skills.
• Detail-oriented, organized, and willing to learn.
• Able to work independently while collaborating with cross-functional teams.
• Proficient in English, both written and spoken.

Job Types: Full-time, Permanent

Pay: RM3,500.00 - RM5,500.00 per month

Benefits:

• Health insurance
• Opportunities for promotion
• Professional development

Work Location: In person