Associate Director, Regulatory Operations

Parabilis Medicines • Cambridge, MA

15d • $165,000 - $200,000

About The Position

Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines that unlock high-impact protein targets long-considered undruggable. The company has developed a new class of stabilized, cell-penetrant alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that are inaccessible to traditional drug modalities. Headquartered in Cambridge, Mass., Parabilis is advancing a focused pipeline of multiple first-in-class therapies across both rare and common cancers. Its lead candidate, FOG-001, is the first direct inhibitor of the interaction between β-catenin and the T-cell factor (TCF) family of transcription factors, implicated in colorectal cancer, desmoid tumors, and a range of other Wnt/β-catenin-driven tumors. Parabilis is also advancing investigational degraders of ERG and ARON for the treatment of prostate cancer, as well as other preclinical programs. What’s the opportunity? The Associate Director of Regulatory Operations will lead strategy, infrastructure, and execution for all regulatory submissions (INDs, CTAs, NDAs), ensuring timely, compliant filings with health authorities (FDA, EMA, APAC HAs) by managing teams, processes, systems (eCTD) and cross-functional collaboration, while staying ahead of changing global regulations and driving operational excellence for growth. This position reports to the Senior Director, Regulatory Affairs and will interact with cross-functional teams, including Clinical Operations, Clinical Development, Biostatistics, Nonclinical Science, and Project Management.

Requirements

• Bachelor’s degree or equivalent experience
• 8-10+ years industry experience
• Expertise in electronic submission standards (eCTD) and regulatory information management (RIM) systems.
• Strong leadership, communication, and problem-solving skills.
• Ability to manage complex projects, priorities, and budgets.
• Deep knowledge of applicable FDA, EMA, and other relevant health authority guidelines
• Demonstrated use of AI tools in your current role and responsibilities is required.

Nice To Haves

• Advanced or innovated use of AI is a strong plus

Responsibilities

• Strategy & Leadership: Define vision for Regulatory Operations, build scalable infrastructure, mentor teams, and provide solutions balancing compliance with business needs.
• Submission Management: Oversee lifecycle of submissions, from planning, formatting, publishing (eCTD), to archiving, managing health authority correspondence and commitments.
• Infrastructure: Implement internal US eCTD submission and Regulatory Information systems including regulatory document templates.
• Process Improvement: Drive continuous improvement, implement best practices, and develop standard operating procedures for efficient, lean operations.
• Cross-Functional Collaboration: Partner with Regulatory Affairs, R&D, Quality, and Commercial teams to ensure integrated, compliant product development.
• Regulatory Intelligence: Monitor global regulatory changes, assess impact, and advise leadership on strategy adjustments.
• Vendor Management: Oversee relationships with external vendors and contractors for systems and technology.

What This Job Offers

• Job Type: Full-time
• Career Level: Director