Regulatory Affairs Manager
Core
Lead product registration and lifecycle management activities for pharmaceutical products across Southeast Asia markets.
Role type
Senior individual contributor Regulatory Affairs Manager
Builds
Product registrations and compliance dossiers for emerging markets
Domain
Pharmaceutical industry, Southeast Asia regulatory landscape
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Product registration lifecycle management, Regulatory dossier preparation, Health authority liaison, Regulatory change monitoring, GDP/GMP compliance, Labeling and packaging review, Regulatory file management, Business partnership due diligence
Preferred skills
Registered Pharmacist status, US/EU/China regulatory submission experience, Biologics/medical devices/vaccines experience, ASEAN CTD and ICH guidelines familiarity
Technologies
HSA, NPRA, BPOM, Thai FDA systems
Responsibilities
Lead product registration and lifecycle management activities for assigned markets across Southeast Asia; Prepare, compile, and submit regulatory dossiers in compliance with local requirements; Manage end-to-end registration processes including new product filings, renewals, and variations; Serve as primary point of contact for Health Sciences Authority and other regulatory bodies; Monitor regulatory changes and assess impact on product portfolio; Ensure compliance with GDP, GMP, and quality management system standards; Review and approve product labelling, packaging, and promotional materials for regulatory compliance; Maintain accurate regulatory files, submission records, and tracking systems; Manage product licenses and ensure timely renewals; Support regulatory due diligence for new business opportunities and product partnerships; Partner with internal teams to align regulatory activities with business objectives; Provide regulatory input on product development, new product evaluations, and launch strategies
Seniority
Senior, hands-on IC
