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Clinical Resource Network (CRN)

Senior Director Regulatory Affairs Strategy & Submissions

Clinical Resource Network (CRN), San Francisco, California, United States, 94199


A San Francisco based biotech company is seeking a Senior Director of Regulatory Affairs Strategy & Submissions to join their growing team. This is a hybrid position, requiring 2-3 days onsite.Salary: $220-$290kResponsibilities:Developing and executing regulatory strategies and operations to move products through all phases.Lead development of regulatory documentationResponsible for all regulatory interactionsProvide regulatory support and guidance to other departmentsManage the filing of all global regulatory submissionsContribute to preparation of IBs, CSRs, and other clinical documents such as clinical study protocols.Review all regulatory documents to ensure submission-readinessVendor managementRequirements:Bachelor's degree within scienceAt least 10 years of experienceRegulatory strategy & submissions experiencePrior experience with expedited programsUS and global experiencePrior Leadership and Management experienceEarly to late stage clinical development experience and post approval experienceIf you meet the required qualifications and are interested in this role, please apply today.Clinical Resource Network DistinctionCRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.About CRNFounded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit and connect with us on Facebook and LinkedIn .Opportunity Awaits.