Senior Director, Regulatory Affairs

Why join us?

Parabilis Medicines is a highly distinctive young biopharmaceutical company whose intention is to grow over time into the ranks of major therapeutics companies.  Our foundational platform of Helicon™ therapeutics are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, Parabilis is poised to revolutionize the medical possibilities for patients by precisely drugging intracellular targets long understood to be significant drivers of disease but never before drugged due to the limitations of existing drug modalities to act within the cell.

An important distinctive element of Parabilis is our lead program FOG-001, the company’s first-in-class TCF-blocking β-catenin inhibitor.  This compound is approximately 18 months and ~50 patients into our early development program for patients with advanced solid tumors, most importantly colorectal cancer. There are few products in the ecosystem with the medical and economic potential of FOG-001. Parabilis is fully leveraging the unprecedented potential Helicons present by deploying proprietary, custom-built machine learning and computational methods as part of its discovery and development process. Parabilis Medicines has raised more than $500 million to date from leading life sciences investors. Parabilis Medicines is headquartered in Cambridge, Mass.

What’s the opportunity?

We are seeking a highly skilled Senior Director, Regulatory Affairs to be at the forefront of driving regulatory success and shaping 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 secure and maintain regulatory approvals across the product lifecycle. Success requires a deep understanding of regulatory frameworks, especially with the FDA, and a demonstrated ability to lead cross-functional teams and external resources toward successful submission outcomes.

The Senior Director will drive regulatory planning, execution, and agency interactions. The ideal candidate brings proven 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

• Define global regulatory strategies and provide cross-functional teams with actionable, tactical guidance to ensure strategy is updated and executed.
• Anticipate and adapt to changes in regulatory and business environments, ensuring strategies remain aligned with evolving requirements.
• Drive end-to-end regulatory planning for submissions including INDs, NDAs/BLAs, briefing packages, and orphan drug applications.
• Oversee regulatory consultants and vendors to ensure timely, compliant, and strategic deliverables. As the company grows, this role will build a team and foster high performance.

Agency Engagement & Communication

• Serve as the primary regulatory liaison for FDA and other global health authorities.
• Prepare and lead company participation in agency meetings, ensuring 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.

Cross-functional Collaboration

• Represent Regulatory Affairs on Project Teams, Clinical Teams, and Study Teams to align regulatory activities with development goals.
• Communicate regulatory strategy, risk, and milestones clearly across internal teams and with external partners.
• Lead cross-functional regulatory submission teams; ensure high-quality contributions from internal and external stakeholders.
• Identify, select and provide oversight to vendors (e.g., CROs)

Compliance & Operational Excellence

• Ensure global regulatory strategies are compliant with applicable regulations and guidances.
• Develop and maintain regulatory SOPs and best practices.
• Maintain up-to-date regulatory intelligence; monitor global regulatory trends, changes in legislation, and health authority expectations.

• Participate in regulatory due diligence and provide strategic input during business development evaluations.

What you’ll need to be successful:

• Bachelor’s degree in a scientific discipline required; advanced degree (MS, PhD, PharmD) preferred.
• 10+ years of experience in the pharmaceutical/biotech industry, with at least 7 years in Regulatory Affairs roles.
• Strong preference for experience in oncology and across multiple development phases.
• Demonstrated expertise in preparing and leading global regulatory submissions, particularly NDA/BLA filings with the FDA.
• Global regulatory experience required.
• Comprehensive knowledge of the drug development process and global regulatory pathways.
• Deep understanding of global regulatory guidelines and their strategic application.
• Excellent interpersonal, collaboration, and leadership skills, with the ability to influence cross-functional teams.
• Highly organized with outstanding communication and project management skills to juggle multiple priorities effectively.
• Proactive, analytical, and detail-oriented problem solver with a strong strategic mindset.

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.

As an equal opportunity employer, Parabilis Medicines values diversity 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