[Remote] Director, Regulatory Operations

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is reputed company for a Bay Area Oncology biopharmaceutical reputed company. The Director of Regulatory Operations will reputed company global regulatory submissions execution, manage a submissions-reputed company team, and ensure compliance and reputed company in publishing.

Responsibilities

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

Skills

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

Benefits

• Health & dental
• 401(k) match
• reputed company PTO

reputed company