[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.ResponsibilitiesLead global regulatory submissions execution across all application types; own timelines and resource modelsManage submissions-focused team and external vendors; ensure timely, compliant, high-quality publishingDevelop, implement, and optimize SOPs, work instructions, and submission procedures across regionsDrive continuous improvement: reduce cycle times, increase predictability, enhance qualityPartner cross-functionally with Medical Writing, Quality, Clinical Operations to ensure seamless submission lifecycle handoffsEnsure submission processes align with Quality systems and FDA inspection readinessSkillsSeasoned people manager with proven track record in regulatory operationsExpert in regulatory publishing (capable backup publisher); Smartsheet proficiency requiredDeep knowledge of FDA submission types and global regulatory dossier requirementsTrack record translating regulatory strategy into executable submission plansStrong cross-functional stakeholder management in biopharmaceutical environmentBenefitsHealth & dental401(k) matchPaid PTOCompany OverviewClindata 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.