Sr Manager Regulatory Surveillance

Job Description:

The Sr Manager for regulatory surveillance will support the regulatory surveillance and intelligence process as well as the inspection readiness process. The position must work cross-functionally across the organization and have excellent communication and collaboration skills.

Responsibilities:

• Responsible for triaging and assessing regulatory surveillance items such as new regulations or guidance.


• Leads cross-functional teams to assess the impact of these regulations to the Vertex organization and associated quality systems and processes.


• Provide guidance and expertise to the team on regulatory expectations, standard practices in the industry, and options for implementation.


• Supports inspection and submission readiness by tracking and reporting progress on various metrics and programs.


• Reports out on KPIs and metri...