Sn Manager/Director Regulatory Affairs - South San Francisco
2 days ago

Job summary
This position provides strategic regulatory leadership for assigned oncology programs with accountability for global regulatory strategy execution and outcomes across various stages of development.- Serve as the primary regulatory spokesperson in formal interactions with the FDA.
- Plan prepare review and submit high-quality regulatory dossiers such as INDs CTAs NDAs/BLAs MAAs.
- Partner with cross-functional stakeholders to ensure clear consistent and strategically aligned messaging across global regulatory submissions.
Qualifications
Demonstrated experience in leading global regulatory strategies and submissions including INDs CTAs and preferably marketing applications (NDA/BLA/MAA). Proven ability to serve as the lead regulatory representative in FDA interactions.Job description
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