Regulatory Affairs And Engagement Manager at Vial
Description
Ready to apply first-principles thinking to a slow and broken drug development regulatory landscape? Join our Corporate Affairs team to forge bold, innovative pathways for groundbreaking therapies.
This role fuses U.S.
and global regulatory needs, perfect for those who excel in entrepreneurial environments where boundaries are meant to be pushed.
What you'll do Run point on our US and global submission strategy: architect, craft, and drive submissions that challenge conventional timelines Help drive and eventually own FDA and international engagements from start to finish: from pre-IND meetings to strategic negotiations that drive breakthrough outcomes Transform regulatory guidance into competitive advantage through differentiated development approaches Create policy that becomes utilized for legislative & public affairs campaigns across the globe Orchestrate global regulatory strategy with precision and impact Collaborate across Corporate Affairs, Operations, and Business / Strategy teams Engineer nimble, scalable systems that accelerate delivery while maintaining scientific integrity You'll be successful if you Thrive on pushing boundaries with calculated risk-taking backed by solid data Excel in fast-paced, ambiguous environments where decisive action trumps perfect information Communicate with razor-sharp precision to both technical teams and executive leadership Relentlessly question conventional approaches while upholding scientific and compliance excellence Qualifications 2-4-ish years of direct Regulatory Affairs with hands-on US IND ownership and direct CDER engagement; global exposure to other health authorities a big plus Track record of commanding FDA meetings and driving submissions from strategy to acceptance Deep mastery of US regulations for early development, with working knowledge of ICH and major ex-US agencies Exceptional scientific storytelling ability across clinical and nonclinical domains Proven cross-functional leadership in high-velocity environments BS in a relevant scientific discipline required; advanced degree a plus Nice to have Experience or desire to implement game-changing approaches: adaptive designs, decentralized trials, digital endpoints, or RWE Early-stage CMC regulatory strategy chops Savvy navigation of ex-US pathways to create strategic advantages Our culture, your fit Builder mindset: we don't just follow playbooks—we create them Bias toward rapid execution, crystal-clear communication, and collective accountability Fearless in proposing unconventional pathways to achieve breakthrough outcomes If you're ready to revolutionize how regulatory affairs drives development at warp speed, we want to talk.
- Role: Regulatory Affairs and Engagement Manager
- Company: Vial
- Location: Washington, DC
- Job found on: 15th of October, 2025
