Senior Specialist, Quality Assurance & Regulatory Affairs
Core
Local implementation of regulatory and quality activities, obtaining marketing authorizations for drugs, biologics, and medical devices, and managing product complaints/recalls in Malaysia.
Role type
Senior Specialist, Regulatory Affairs & Quality Assurance
Builds
Marketing authorizations, compliant labeling, quality documentation, and recall procedures for pharmaceutical and medical device products.
Domain
Healthcare (Pharmaceuticals, Biologics, Medical Devices) in Malaysia
Required skills
Regulatory project planning, risk identification, compliance with GDPMD and local regulations, complaint investigation, root cause analysis, supplier quality management, SOP development, audit management, labeling review, adverse event reporting
Preferred skills
Pharmacist license, experience with new registration/license extensions/variations/renewals, project management, multitasking
Technologies
Word processing, spreadsheets, databases, online research systems
Responsibilities
Develop and execute regulatory project plans, respond to regulatory authority inquiries, compile and submit regulatory documents, prepare and approve labeling, manage product complaints and recalls, oversee documentation control and GDP compliance, manage internal/external/supplier audits
Seniority
Senior, hands-on IC