[Remote] Director, Regulatory Operations
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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