Pfizer Regulatory Affairs Coordinator in HQ, Brazil
This position will be responsible to liaise with global and local regulatory colleagues in order to: - Coordinate the actions related to submissions post-approval changes/History Product Changes and License Renewals for all Pfizer`s Essencial Products.
Provides regulatory intelligence to the global stakeholders and maintains the country regulatory knowledge/intelligence in RRM.
Coordinates and defines regulatory strategy within region for lifecycle submissions.
Manages regional planning and monitoring activities to execute submission plans.
Identify potential artwork/labelling impact of CMC submissions
Supports requests for non-CMC ancillaries and samples as applicable.
Manages submission/approval updates for CMC submissions in the conformance systems
It is required graduation in Pharmacy and at previous experience in regulatory affairs in Brazil. Advanced English required.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.