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.
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