Associate Director, Regulatory Affairs

The posting, as Parabilis Medicines wrote it

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 .

What’s the opportunity?

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.

Key responsibilities

Regulatory Strategy & Execution

• 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.

Agency Engagement & Communication

• 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 ris

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bility to travel up to 10%.

Core Values

Parabilis Medicines is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients. The company is committed to promoting an inspiring and flourishing working environment for all employees across the business, in all departments, and driving innovation for patient benefit.

• Growth-Minded . We’re inventing a new class of medicines—one applicable to therapeutic targets that have been dreamt about, but always considered impossible to drug. Our work requires us to be curious, humble and adaptable.
• In(ter)dependent. We are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options.
• Patient-focused. We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact.
• All-In. We’re All-In on solving some of the hardest scientific challenges and delivering one of the most effective new classes of drugs in history.

The base salary range for this position is $170,000-$195,000, depending on experience, qualifications, and internal practices. Parabilis’s total compensation package also includes an annual target bonus, equity, and a comprehensive suite of competitive benefits designed to support our employees’ overall well-being.

As an equal opportunity employer, Parabilis Medicines values an inclusive workplace and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

30 Acorn Park Drive | Cambridge, MA 02140 | www.parabilismed.com