The job posting is for a 12-month contract position at Merz Asia Pacific Pte. Ltd. in Singapore, focusing on regulatory affairs, quality assurance, and pharmacovigilance for pharmaceutical, medical device, and cosmetic products. The role involves ensuring compliance with global regulations, supporting product registrations, and maintaining quality systems
Job Summary
This position supports regulatory affairs, quality assurance, and pharmacovigilance activities for pharmaceutical, medical device, and cosmetic products across APAC markets.
The role involves leading agency interactions, preparing dossier submissions, and ensuring compliance with global and regional regulatory requirements.
Candidates will act as a deputy PVRloc, manage adverse event reports, and participate in regulatory inspections and quality management reviews.
Matching Summary
Match Score: 85
The job posting is for a 12-month contract position at Merz Asia Pacific Pte. Ltd. in Singapore, focusing on regulatory affairs, quality assurance, and pharmacovigilance for pharmaceutical, medical device, and cosmetic products. The role involves ensuring compliance with global regulations, supporting product registrations, and maintaining quality systems.
Skills & Requirements
Must-have
Regulatory submission preparation
GxP compliance maintenance
Adverse event reporting processing
Agency interaction management
Quality Management System implementation
Nice-to-have
Cross-functional collaboration skills
APAC market regulatory knowledge
Training and development experience
Audit preparation capabilities
Key Requirements
Knowledge of cGMP and GVP guidelines
Experience with regulatory change control responses
Ability to coordinate stock build with Supply Chain