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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
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Strengthen internal gene therapy CMC capability by working with internal stakeholders and external partners to evaluate and enable gene therapy related GTP/GMP facility Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
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Coordinate CMC portfolio plans with global company plans, internal manufacturing site production plans, contract manufacturing production plans, clinical development plans, CMC regulatory filings Focus on continuous improvement of team capabilities by ensuring that partner team leads have the opportunity for training and development to excel in their role as functional representatives and cross-functional team members.
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Must be professionally licensed by the State of California, Board of Behavioral Sciences as a Licensed Clinical Social Worker, Licensed Marriage and Family Therapist, or a Licensed Professional Clinical Counselor OR must be professionally licensed as a Clinical Psychologist issued by the State of California Department of Consumer Affairs, Board of Psychology.
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Assist the Director of Operations, S&S Manager, Plant Safety Supervisor, Plant Safety Steering Committee and Corporate Safety Director in preparing for the Corporate Safety Audit or any safety related audit, including regulatory inspections within the facility.
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U00A0 S/he will lead the global Integrated Brand Teams (PKU and ERTs) with representation from Strategic Markets, Regions, Value and Access, Medical Affairs, Worldwide R&D, Supply Chain, and other key stakeholders to develop a cohesive, insights-based global brand strategy across the product life cycle.
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Manage the GAAP classification process Perform ERP administrative tasks (e.g., maintain manager posting limits, delete unposted journal entries, monitor and delete records in the GL interface table, fix corrupted Balances, add a missing FX rate, rereview COA audit report, COA local to GAAP mapping, CMAAR Med Affairs Allocation, etc.
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The Director, US Achondroplasia HCP Marketing Lead is responsible for overarching HCP vision, strategy and tactics for the cross-functional brand team for Voxzogo in achondroplasia and lifecycle opportunities in the US. They must be a seasoned leader who can influence without direct reporting relationships across all key stakeholder teams in the US (sales, reimbursement hub, market access, global product strategy, medical affairs, compliance, learning and development, etc.
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Develop collaborative relationships with various groups internally and externally, including clinical and support staff, other departments, management, Sutter Health clinical nurse educators, college staff, regional CPR training program coordinators, and regulatory agencies to coordinate educational needs and ensure compliance.
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This position will support UCLA’s best-in-class fundraising program, alumni affairs programs that connect Bruins worldwide, the outreach and engagement activities of our government and community relations team and all the important back office processes and functions of our External Affairs organization.
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Support the Supply Chain Operations department as the primary point of contact for Ready process and Inventory as well as partnering closely with the OPS, Quality, Regulatory, CMO’s, Finance, and Projects group.
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Partner within GxP Compliance and cross-functional departments regularly i.e., Pharmacovigilance Operations, Regulatory Affairs, Global Medical Affairs, Global Study Operations and Commercial to obtain regulatory intelligence, business risk area guidance, and consultation to anticipate upcoming auditing needs.
$119,400 - $179,200 a yearFull-timeExpandApply NowActive JobUpdated 29 days ago - UpvoteDownvoteShare Job
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1035 Public Affairs Specialist. Disabled veterans rated by the Department of Veterans Affairs (VA) as having a compensable service-connected disability of 30 percent or more. 1084 Visual Information Specialist.
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Develop reporting and analysis tools to support HR data management and regulatory compliance. Develop reporting and analysis tools to support HR data management and regulatory compliance. Jointhe Pasha Group , a family-owned diversified global logistics and transportation services company since 1947.
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Plan, organize, direct, and supervise operations, maintenance, and services activities within an assigned section of the Department of Public Works and Utilities, including street maintenance and repair, painting, signage, fleet services and/or water distribution, storm drains, and wastewater collection system maintenance and operations; ensure compliance with operational and regulatory requirements; perform a variety of technical tasks relative to assigned area of responsibility.
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regulatory affairs jobs Company: Verizon in Novato, CA
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