[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