Chile_Technical Manager
Core
Manage product registration, regulatory compliance, and pharmacovigilance for biosimilar and innovative biopharmaceutical medications in Chile.
Role type
Technical Manager (Regulatory & Pharmacovigilance)
Builds
Regulatory compliance and product lifecycle management for biopharmaceuticals
Domain
Biopharmaceuticals / Regulatory Affairs
Deliverable
client delivery
Required skills
Product registration management, Sanitary registration renewal, Good Storage Practices (GSP) and Good Distribution and Transportation Practices (GDTP) certification, Pharmacovigilance management, Import process oversight, Marketing material compliance review, Adverse event reporting, Training delivery
Preferred skills
Knowledge of public bidding processes, Customs documentation, Local labeling approval
Technologies
None stated
Responsibilities
Ensure product registration and renewal, Coordinate with laboratories and agencies, Oversee import processes, Manage pharmacovigilance and safety reporting, Review marketing materials, Provide training on pharmacology and pharmacokinetics, Handle medical information inquiries
Seniority
Manager, hands-on IC