Chile_Technical Manager
Core
Manage product registration, regulatory compliance, and pharmacovigilance for biosimilar and innovative biopharmaceutical medications in Chile.
Role type
Regulatory Affairs Manager (Pharmaceuticals)
Builds
Regulatory filings, safety reports, and compliance documentation for global biopharmaceutical products.
Domain
Biopharmaceuticals / Regulatory Affairs
Deliverable
client delivery
Required skills
Product registration management, Good Storage Practices (GSP), Good Distribution and Transportation Practices (GDTP), pharmacovigilance, import licensing, adverse event reporting, marketing material compliance review, training delivery, medical information handling.
Preferred skills
Knowledge of local Chilean pharmaceutical regulations, experience with public bidding processes, familiarity with clinical trial data.
Technologies
Regulatory submission systems, pharmacovigilance databases, document management systems.
Responsibilities
Ensure timely registration and renewal of product sanitary registrations; coordinate with laboratories and agencies for quality assurance; issue GSP and GDTP certificates; manage public bidding processes for legal authorization; oversee import processes and approve storage conditions/labeling; act as safety and complaints officer for adverse events; review marketing materials for policy compliance; provide training on pharmacovigilance and pharmacology; handle medical information inquiries.
Seniority
Manager, hands-on operational leadership
