Associate Regulatory Affairs Strategy Director (Oncology)
Exelixis
📍 Alameda, California, United States
Job Description
SUMMARY/JOB PURPOSE:
Responsible for the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health authority requirements. Ensures timely preparation of organized, consistent, and scientifically valid submissions. Provides expertise in translating regulatory requirements into practical, workable plans. Communicates clearly with stakeholders to reduce regulatory risk and drive the implementation of appropriate mitigation strategies.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Interact directly with regulatory authorities.
Conduct effective and timely regulatory intelligence and research to provide guidance to study and asset teams. Provide risk assessments and recommendations for various regulatory scenarios, including possible expedited pathways.
Represent Regulatory Affairs in multi-disciplinary teams to establish development and regulatory strategies for...