Note: The job is a remote job and is open to candidates in USA. Clindata Insight Inc is recruiting for a Bay Area Oncology biopharmaceutical client. The Director of Regulatory Operations will lead global regulatory submissions execution, manage a submissions-focused team, and ensure compliance and quality in publishing.

Responsibilities

• Lead global regulatory submissions execution across all application types; own timelines and resource models
• Manage submissions-focused team and external vendors; ensure timely, compliant, high-quality publishing
• Develop, implement, and optimize SOPs, work instructions, and submission procedures across regions
• Drive continuous improvement: reduce cycle times, increase predictability, enhance quality
• Partner cross-functionally with Medical Writing, Quality, Clinical Operations to ensure seamless submission lifecycle handoffs
• Ensure submission processes align with Quality systems and FDA inspection readiness

Skills

• Seasoned people manager with proven track record in regulatory operations
• Expert in regulatory publishing (capable backup publisher); Smartsheet proficiency required
• Deep knowledge of FDA submission types and global regulatory dossier requirements
• Track record translating regulatory strategy into executable submission plans
• Strong cross-functional stakeholder management in biopharmaceutical environment

Benefits

• Health & dental
• 401(k) match
• Paid PTO

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