Director of Regulatory Operations

Director - Regulatory Operations
📍 Remote (U.S.-based) | Full-time
💰 Salary Range: $200,000 - $280,000 + Bonus + Equity

Build the regulatory infrastructure that powers global drug development.

This is a rare opportunity to lead the creation and evolution of the Regulatory Operations function at a fast-growing biotech company. If you're ready to move beyond execution and into strategic ownership-where your work directly enables clinical progress and global approvals-this is the role for you.

🚀 Why This Role Matters

• Foundational Leadership: You'll architect the systems, processes, and tools that support global regulatory submissions-from INDs to BLAs.
• High Visibility: Collaborate across Regulatory, Clinical, Quality, and IT to drive operational excellence and ensure compliance.
• Global Impact: Your work will enable timely, high-quality submissions that help bring therapies to patients worldwide.
• Innovation-Driven Culture: Be part of a team that values agility, transparency, and continuous improvement.

🧠 What You'll Bring

• 10+ years in Regulatory Operations within biotech or pharma
• Expertise in Veeva RIM and electronic submission standards
• Strong project management and cross-functional collaboration skills
• Experience leading publishing, archiving, and document management for global submissions
• A proactive mindset and ability to thrive in a build-and-scale environment

🎯 What You'll Do

• Lead regulatory operations strategy, infrastructure, and execution
• Oversee submission planning, formatting, publishing, and archiving
• Manage Health Authority correspondence and commitments
• Collaborate with vendors and internal teams to ensure timely, compliant submissions
• Monitor evolving regulatory standards and implement best practices
• Support transparency and disclosure initiatives (e.g., clinicaltrials.gov, CTIS)

💼 What You'll Get

• Strategic Ownership: A leadership role where your decisions shape regulatory success and operational efficiency.
• Executive-Level Compensation: Competitive base salary, performance bonus, and equity participation.
• Comprehensive Benefits: Health coverage, 401(k) match, stock purchase plan, generous PTO, paid parental leave, and tuition assistance.
• Remote Flexibility: Work from anywhere in the U.S. while staying connected to a collaborative, mission-driven team.
• Inclusive Culture: Join a company committed to diversity, equity, and innovation-where your background and perspective are valued.

This is your opportunity to lead with purpose and build something that lasts.
Apply confidentially to learn more.