JOB SUMMARY
Summarize the primary purpose & key accountabilities of the job.
- Provide managerial oversight to the Regulatory Organization to execute regulatory strategies.
- Support the Head of Regulatory Sciences Mexico to achieve the regulatory authorizations in the Country, within the legal standards and established timelines.
- Coordination and implementation of consistent standards and processes.
- Compliance with Sanitary regulations and corporate policies.
- Actively participate in meetings with representatives of Regulatory Agency, other Regulatory Agencies, and Trade Associations.
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 tim...