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

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Job ID:00403344Job329of371Regulatory Senior Product Manager-Location: SingaporeSouth 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 PositionThe Regulatory Senior Product Manager will provide Technical Regulatory leadership and oversight to the Roche Singapore Site. The incumbent will provide technical regulatory support for impact assessment to change control, discrepancy management and inspection management systems. He/she will coordinate and track regulatory commitments related to the site. The position will work closely with Roche Singapore Quality Assurance, Manufacturing, Quality Control, Validation, Manufacturing Sciences and Technology, Biologics Manufacturing Network and Global Technical Regulatory groups to assure the relevant product and regulatory expectations are met. He/she will be responsible for timely compilation and management of all necessary documentation for regulatory submissions to support the CMC section of license applications and post-approval supplements. He/she will ensure submissions are of high quality; that content and format of regulatory submissions comply with applicable regulations and guidelines governing the development, licensure and marketing of drugs and/or biologics.He/she will lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and personalities. The candidate will support ex-US filings, as appropriate and as requested by corporate partners. Additional responsibilities will include supporting departmental operational excellence and business process initiatives, as well as, proactively communicate with Regulatory and cross functional personnel and partners in support of internal and partner associated goals.The Regulatory Senior Product Manager must maintain a high level of professionalism, efficiency, and follow-through as the primary technical regulatory liaison for the assigned site. The successful candidate will demonstrate effective problem solving, strong understanding of CMC regulatory, excellent interpersonal skills and the ability to prioritize multiple tasks. Must have a proven ability to communicate effectively in both a written and verbal format. Ability to work both independently or collaboratively in a team structure. Have a proven ability to work well under pressure. The incumbent will be skilled to lead communications with FDA and regulatory agencies to facilitate review and approval of submissions.Who You AreRequirements: The candidate must possess at least Bachelor

KEY REQUIREMENTS:

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