Process management for drug registration and renewal
The role ensures compliance of the Medley portfolio with ANVISA by leading registration, renewal, and post-registration change processes
Job Summary
The role ensures compliance of the Medley portfolio with ANVISA by leading registration, renewal, and post-registration change processes.
Candidates will collaborate with Quality, Pharmacovigilance, Operations, and the Campinas factory to align regulatory documentation with production processes.
This position offers the opportunity to work within a dynamic team at one of Brazil's largest generic medicine companies, directly impacting patient access to quality medications.
Matching Summary
The role ensures compliance of the Medley portfolio with ANVISA by leading registration, renewal, and post-registration change processes.
Skills & Requirements
Must-have
Experience in pharmaceutical regulatory affairs
Knowledge of Brazilian health legislation ANVISA
Process management for drug registration and renewal
Ability to respond to regulatory authority requirements
Competitive intelligence on pharmaceutical market
Nice-to-have
Intermediate or advanced English proficiency
Collaborative teamwork across technical areas
Strategic thinking for regulatory alignment
Commitment to ethics and integrity principles
Key Requirements
Degree in Pharmacy, Biochemistry, Chemistry, or related field
Experience in synthetic generic and similar drug registration