PR/159172 | PV / RA / QM Specialist

Company and Job Overview

Our client specializes in manufacturing and selling medicinal and pharmaceutical products. As part of their expansion, they are now seeking a PV/RA/QM Executive to handle the submission and management of regulatory changes for pharmaceutical products in Malaysia and Singapore.

Job Responsibilities

• Staying informed about regulatory requirements, ensuring compliance, and communicating with global, regional, and local teams.
• Handling safety event reviews and submissions to both Global Pharmacovigilance and local health authorities.
• Managing registration dossiers for regulatory approvals and maintaining local licenses.
• Evaluating change requests and their regulatory impact.
• Reviewing product labeling for compliance with branding and regulations.
• Leading or supporting local Good Distribution Practice (GDP) inspections.
• Assisting in addressing deviations and product complaints while monitoring their resolution status.

Job Requirements

• Bachelor’s Degree in Pharmacy, Life Sciences or equivalent
• 1- 2 years of experiences in RA and/or PV in pharmaceutical industry.
• Malaysian licensed Pharmacist preferred.
• Good analytical and problem-solving skills with the ability to interpret complex regulatory requirements
• Strong organizational and process management skills. Able to multi-task effectively.
• Proven ability to effectively build lasting relationships by demonstrating strong interpersonal and influencing skills throughout all levels of the organization.
• Teamwork and collaboration with cross functional teams.
• Excellent verbal and written communication skills in English.

Additional Details

• 5 days' work
• Remote work