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
Interested applicants, feel free to click APPLY NOW.
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