Regulatory Affairs Manager
Core
Manage regulatory compliance, submissions, and pharmacovigilance for medical devices and drugs in Indonesia.
Role type
Senior Regulatory Affairs Manager (Pharmacovigilance)
Builds
Product registrations, regulatory submissions, and safety reporting for kidney care products
Domain
Healthcare / Medical Devices / Pharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
regulatory strategy, pharmacovigilance operations, adverse event management, audit support, product lifecycle management, stakeholder negotiation, SOP development, regulatory intelligence
Preferred skills
experience with Indonesian health authorities (BPOM), crisis management, project management
Technologies
regulatory databases, SOP frameworks
Responsibilities
Prepare and execute regulatory submissions and annual reports; manage pharmacovigilance operations and adverse event reporting; maintain product licenses and registrations; support external audits; review product labels and promotional materials for compliance; lead negotiations with health authorities.
Seniority
Senior, hands-on IC
