Responsibilities will include, but are not limited to, the following:
Develop and implement global regulatory strategy for assigned projects, along with Regional Regulatory Affairs representatives and Regulatory CMC. Lead global and/or regional regulatory team on assigned projects. Develop and execute US regulatory strategy and contingencies for assigned projects. Serve as the primary interface for FDA on assigned projects. Lead the preparation of submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc. Work with cross-functional teams to define contributions to submissions. Lead regulatory submission teams for projects assigned. Prepare project/study team for FDA and other regulatory health agency meetings, as required. Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Development Teams and Study Teams, etc. Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances. Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
Domestic and occasional International travel may be necessary.
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.