Backed by General Catalyst and GV.
About the role
We are seeking a highly skilled Senior Manager/Associate Director, Regulatory Operations to support and help drive regulatory success and shape the development of life-changing treatments. In this role, you will provide operational leadership supporting global regulatory submissions, regulatory information management, regulatory technology, publishing, and Health Authority interactions across development programs.
What they're looking for
- Bachelor's degree in Life Sciences or related discipline, or equivalent combination of education and relevant Regulatory Operations experience
- Approximately 6-10 years of Regulatory Operations experience within the biotechnology or pharmaceutical industry
- Extensive experience supporting FDA electronic submissions
- Strong knowledge of eCTD publishing and submission lifecycle management
- Experience with Veeva Vault RIM or Veeva RIM Basics
- Experience supporting regulatory information management systems
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 Senior Manager/Associate Director, Regulatory...
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