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
Company Overview
Clindata Insight is a biometrics consulting firm based in the San Francisco Bay Area specializing in biostatistics, statistical programming, CDISC implementation, big data for life science and talent solutions. It was founded in 2013, and is headquartered in Moraga, California, USA, with a workforce of 11-50 employees. Its website is https://www.clindatainsight.com.