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Job Field: Government Jobs
Location: United States, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Job ID:00405894Job250of371Senior Regulatory Associate, Development Biologic ProductsSouth San Francisco, CaliforniaJob factsJob functionTechnical OperationsLocationUnited States - CaliforniaSouth San FranciscoCompany / DivisionPharmaceuticalsScheduleFull-timeJob typeRegular EmployeeJob levelExperiencedServiceDirect linkApply OnlinePrintWho We AreAt the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we''ve become one of the world''s leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.The PositionAs a Senior Associate within Pharma Technical Regulatory, you will be responsible for the timely filing of Chemistry, Manufacturing and Controls (CMC) section of Investigational New Drug Applications, with a primary focus on biologics products in the Development portfolio. You will manage the preparation, assembly, review, and submission of Regulatory documentation such as applications, amendments and correspondences with health authorities, as appropriate. The successful candidate will ensure that the quality, content, and format of Regulatory submissions comply with applicable regulations and guidelines. Effective communication with external partners and global regulatory agencies to facilitate review and approval of submissions will be required, along with participation in cross-functional project teams. Applicants must have strong ability to work effectively across multiple disciplines and personalitiesWho You AreThe position requires a candidate with strong written skills, effective interpersonal communication and organizational abilities. Demonstrated ability to coordinate and influence cross-functional teams is also important. A Bachelor

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