Aurora Sosa
Regulatory Affairs Strategist and Leader
- Role
- Senior Director, Global Regulatory Lead at Immunome, Inc.
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Aurora Sosa
A regulatory affairs professional with over 30 years of combined QA/RA pharmaceutical industry experience; 20 years of which is FDA and international regulatory expertise. Demonstrated leadership in building regulatory teams and developing people. Expertise demonstrated in NDA planning, building and submission (including managing Complete Response Letter strategies and submissions). Also expertise demonstrated in planning and submitting IND\'s/ CTA\'s, IMPD;s and MAA development, Orphan Drug Applications, Fast Track, QIDP, Breakthrough, Priority Review and Accelerated Approval Applications, annual report preparation (DSUR and annural reports) as well as management of safety reporting and safety management plans. Experise in labeling, advertising, and marketing, development of international regulatory strategies and submissions as well as project management for new and post marketed product development. Demonstrated leadership in supporting team members in learning these skills.
Experience
Senior Director, Global Regulatory Lead
Apr 2025 — Present · Bothell, WA, US
Education
Trinity University
BS
Baylor College of Medicine
2 years towards PhD
John F. Kennedy University
MA
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