Summary

• Support Regulatory Lead in the preparation of HA interactions (meeting preparation, rehearsals, execution, follow-up, minutes, etc.)

• Maintain tracking data for health authority meetings, PMRs/PMCs, and other key regulatory milestones and liaise cross-functionally to generate periodic internal milestone reports

• Provide operational support on strategic regulatory documents to help drive timely deliverables

• Drive operational excellence in Global Regulatory Strategy & Policy through projects aimed to support collaboration and improve efficiency

• Additional responsibilities, in conjunction with regional and/or global regulatory leads, include:

o IND, BLA, and NDA maintenance submissions

o Safety and Annual report submissions (regulatory components)

o Coordinating and driving rapid response team meetings to ensure quality and timely responses to health authority queries. This includ...