Regulatory Science Coordinator
PFIZER
Ort der Stelle
Mexico
Status der Beschäftigung
Vollzeit
Job-Details
Job summary
Coordinate activities related to dossier submission (paper and/or electronic) for Innovative drug products for country acceptability in terms of content, according to local regulations and requirements. This includes HA query management.
Interact with key stakeholders, such as the LatAm Regional Hub to ensure the regulatory strategy has been executed in a timely manner.
Familiarize themselves with the latest changes in BoH legislation, and communicate this to the LatAm Regional Hub, to ensure the necessary systems and databases are updated as necessary.
Work in collaboration across the region to deliver efficiencies in regulatory submissions and processes.
Accountable for the Labeling and Non-Labeling submissions execution ensuring country acceptability in terms of content and alignment to local regulations and requirements. This includes BoH query management.
Ensures the processes transparency and excellence in execution of regulatory strategies.
Work in collaboration across the organization with stakeholders (such as Product Strategist, Commercial, Operations) to deliver efficiencies in Regulatory submissions and processes.
Participation with Manager or Sr. Manager to provide suggestions or comments in the documents worked by Trade Association
