Associate Director, Regulatory Affairs

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,  or follow us on Linked In.

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,  or follow us on Linked In.

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. Success requires a solid understanding of regulatory frameworks, especially with the FDA, and a demonstrated ability to collaborate effectively with cross-functional teams and external resources toward successful submission outcomes.

The Associate Director will support regulatory planning, execution, and agency interactions. The ideal candidate brings solid global experience navigating complex regulatory environments, particularly in oncology and rare disease, and thrives in a dynamic, mission-driven biotech setting.

• Contribute to the definition of global regulatory strategies and provide cross-functional teams with actionable, tactical guidance to help ensure strategy is updated and executed.
• Anticipate and adapt to changes in regulatory and business environments, ensuring strategies remain aligned with evolving requirements.
• Support end-to-end regulatory planning for submissions including INDs, NDAs/BLAs, briefing packages, and orphan drug applications.
• Support oversight of regulatory consultants and vendors to help ensure timely, compliant, and strategic deliverables.

• Serve as a regulatory liaison for FDA and other global health authorities, as assigned.
• Prepare materials and support company participation in agency meetings, helping ensure internal teams are well-prepared and aligned.
• Proactively communicate regulatory risks, timelines, and updates to senior leadership and core project teams.
• Prepare company for FDA and other health agency meetings, as required.