Temporary Regulatory Affairs Operations Senior ...

OverviewTemporary Regulatory Affairs Operations Senior Specialist — Sangamo Therapeutics, Inc. Location: Richmond, CA or Remote (US Only & in Pacific time zone). This is a temporary position. Visa sponsorship is not available for this role.DetailsTitle: Temporary Regulatory Affairs Operations Senior SpecialistManager: Senior Director, Regulatory AffairsDepartment: Regulatory AffairsLocation: Richmond, CA or Remote (US Only & in Pacific time zone)About SangamoSangamo Therapeutics is a genomic medicine company focused on treating debilitating neurological diseases, by using our zinc finger epigenetic regulation technology and capsid delivery engine. We are dedicated to building a robust, sustainable genomic medicine pipeline to address life-limiting conditions and to creating an inclusive environment that promotes and values diversity.Job SummaryWe are seeking a temporary Regulatory Affairs Operations Senior Specialist to join our team, ensuring Sangamo meets US and EU regulatory submission requirements. The successful candidate will be responsible for coordination, preparation, tracking and filing of document packages for regulatory submission from all areas of research and development.This is a temporary position.We are only considering candidates in the Pacific time zone who currently reside in the United States.Visa sponsorship is not available for this role.Essential FunctionsPreparation, coordination, compilation, formatting, and filing of global regulatory submissions, including INDs, CTAs, BLAs, Drug Master Files, DSURs, Meeting Materials and IND amendments providing for changes in the clinical program and manufacture of the product.Understand electronic common technical document (eCTD) submission requirements in both the US and EU and interface closely with publishing vendor(s) to process, validate and approve eCTD submissionsMaintain/archive all regulatory submissions and correspondence for company sponsored projects, and all company related sections for partner sponsored projects.Responsible for business administration of Regulatory systems (SharePoint, InSight Publisher/Viewer and Veeva Vault RIM), including (but not limited to) user management, training, issue escalation and resolution and working with IT and third-party providers.Maintain up-to-date knowledge of global standards and procedures for regulatory submissions and publishing standards, including eCTD and CTA; analyze new guidance documents and requirements related to electronic submissions, and recommend courses of action.Prepare special reports and assemble documentation to support department activities as neededIdentify process improvements and automation opportunities to increase operational efficiency while ensuring submission integrity.Ensure that issues are identified at an early date and actively contribute to issue resolution before filing dates are impacted.Education, Experience and SkillsBachelor's degree, preferably in a scientific/technical discipline, or equivalent work experience3+ years of regulatory operations experienceExcellent document formatting and publishing skills using MS Word (emphasis on document formatting), Adobe Acrobat, PowerPoint and ExcelExperience in eCTD filingsExperience in European Regulatory submission policies and practicesHands-on experience in SharePoint, eCTD Publishing Tools (InSight Publisher/Viewer), Veeva Vault RIM, and tools like DXC Toolbox that support Regulatory publishingDetail-oriented with the ability to deliver accurate resultsAbility to execute operational processes and quality checks to ensure regulatory complianceFlexibility to adapt to quickly changing processes, priorities, and deadlines with strong problem-solving skills for non-routine issuesWillingness to embrace a culture of flexibility and innovation with urgency and commitment to translating science into genomic therapiesEqual OpportunitySangamo is an equal opportunity employer. We are committed to fostering belonging for all employees and embrace diversity, equity, and inclusion in recruiting and hiring. All qualified applicants will be considered without regard to race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws.Pay RangeThe anticipated salary range is for candidates who will work in our Bay Area locations. The final salary offered will depend on factors including experience, education, and location. This salary range may not apply to remote positions that work in other states. #J-18808-Ljbffr

Created: 2025-09-30