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Regulatory Affairs Specialist

hace 2 meses


Ciudad de México, Ciudad de México MMATISS A tiempo completo

Key Responsibilities:

As a Regulatory Affairs Coordinator at MMATISS, you will be responsible for ensuring compliance with local regulations by performing submissions and tracking the progress of approvals. You will implement regulatory processes to avoid warnings or rejections, including obtaining protocol, site, marketing, and importation/exportation approval. Additionally, you will provide training to Clinical Operations personnel on regulatory matters to promote compliance with all applicable regulations.

Regulatory Monitoring:

You will monitor all regulations in the region to maintain systems in compliance. This includes staying up-to-date on changes to regulations and ensuring that all processes and procedures are aligned with the latest requirements.

Collaboration and Communication:

You will work closely with the Clinical Operations team to ensure that all regulatory requirements are met. You will also communicate with stakeholders to provide updates on regulatory progress and address any concerns or questions they may have.