Jennifer Newman
Executive Director, Regulatory Strategy
- Role
- Executive Director at Celldex
- Location
- New Haven, CT, US
- LinkedIn followers
- 500 followers
About Jennifer Newman
Regulatory Affairs leader driving global regulatory strategy and execution for highly innovative development-stage products from pre-IND through late-phase clinical development. Proven success leading FDA and EMA interactions, securing critical feedback, and delivering high-quality IND, CTAs, and EU CTR submissions.Recognized for advancing complex programs under accelerated timelines, aligning cross-functional teams, and transforming regulatory strategy into a competitive advantage. Deep expertise in drug development and regulatory submissions across multiple regions.I bridge science, strategy, and execution—aligning cross-functional teams, anticipating challenges, and navigating evolving regulatory landscapes to accelerate development and bring transformative therapies to patients.
Experience
Executive Director
Jan 2026 — Present
Education
Northeastern University
MS (not completed), Regulatory Affairs for Drugs, Biologics and Medical Devices
2010 — 2016
Fairfield University
Bachelor of Science (BS), Biology
1991 — 1995
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