Backed by General Catalyst and GV.
About the role
We are seeking a highly skilled Associate Director, Regulatory Affairs to support and help drive regulatory success and shape the development of life-changing treatments. In this role, you contribute to the development and implementation of a consolidated regulatory strategy (including Regulatory Operations) to help secure and maintain regulatory approvals across the product lifecycle.
What they're looking for
- Bachelor’s degree in a scientific discipline or equivalent work experience required, advanced degree (MS, PhD, PharmD) preferred
- 7+ years of experience in the pharmaceutical/biotech industry, with at least 4 years in Regulatory Affairs roles
- Experience in oncology and across multiple development phases required
- Demonstrated experience preparing and supporting global regulatory submissions, particularly NDA/BLA filings with the FDA
- Global regulatory experience preferred
- Solid working knowledge of the drug development process and global regulatory pathways
More about this role
About Parabilis Medicines
Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking biologically important targets long considered undruggable. The company has pioneered a new class of alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that have historically been beyond the reach of conventional medicines. The company’s lead investigational medicine, zolucatetide, is the first and only direct inhibitor of the β-catenin:TCF interaction, a central node in the Wnt/β-catenin pathway that has eluded drug developers for decades. Zolucatetide is being evaluated in the clinic across multiple Wnt/β-catenin-driven diseases, including desmoid tumors, familial adenomatous polyposis (FAP) and a range of other solid tumor indications. Beyond zolucatetide, Parabilis is advancing additional Helicon-based programs focused on other challenging targets where we believe our medicines could have life-altering impact. For more information, visit www.parabilismed.com or follow us on LinkedIn .
We are seeking a highly skilled Associate Director, Regulatory Affairs to...
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