In this role, you will be responsible to support the implementation of various process improvement projects working directly with key stakeholders in all business units as well as our international counterparts to accelerate route to market access.
In this role, you will be responsible for review and prepare regulatory documents for submission to FDA in compliance with requirements. Documents may include Agency Meeting Requests, Briefing Documents, CMC and Labeling supplements, General Correspondence, Annual Reports and Periodic Safety Reports.
As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.
In this role, you will prepare documentation meeting regulatory requirements, identifying and using existing documentation where possible, or managing creation of new documentation; provide to foreign Regulatory affiliates to support product registration.