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The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum’s gene therapy program/s. Manage the Regulatory Affairs (CMC) Strategy for Regulatory Affairs.
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Student Affairs, academic or work experience related to the fields of social work, community organizing, arts & media organization, student affairs, counseling psychology, race & ethnic studies.
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Minimum of 5 years of experience as a Developer/Business Systems Analyst with a focus on QMS in the medical device industry, including expertise in Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
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Requirements:Advanced degree in life sciences in one or more of the following: MD, DO, PharmD, PhD, and 2+ years of relevant Medical Affairs (medical device/pharmaceutical industry), managed care, and HEOR experience, required.
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Extensive experience in late phase drug product development and commercial development with CMC regulatory filings for US (NDA), Europe (MAA), Japan, and China. Thorough understanding and working experience of pharmaceutical drug product with respect to GMP, quality systems, ICH guidelines, FDA, EMA and associated regulatory requirements.
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This role will partner with Clinical Affairs, Medical Affairs, Regulatory, Business Development, Product Development and other cross-functional teams to establish and execute short- and long-term GAVE strategic plans.
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Manage submissions for regulatory reporting and benchmark surveys. The HR Data Analyst III will cultivate a data-driven decision-making culture by providing data visualization and presentation through data extraction, analysis, and standard/dashboard reporting.
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This exciting and influential role will serve as Synopsys' strategist and engagement lead for State and Local Government Affairs, including legislative, regulatory and policy objectives and ensure the integration and execution of these objectives to support the State and Local and broader Government Affairs strategy.
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Experience advising clients on global policy matters, new legislative and regulatory developments, and legal and policy advocacy options and strategies. You will report to Verkada’s Deputy General Counsel and Chief Privacy Officer and play a significant role in shaping the direction of the privacy and AI programs.
$215,000 - $325,000 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Author/review and/or coach team members to author CMC regulatory sections of IND/INDa. Contribute to regulatory strategies and support associated agency interactions and product-related inspections.
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Meta is seeking a highly motivated, organized, detail-oriented candidate to assist the Payments Compliance Team as an Investigator on the Transaction Monitoring Team. The Transaction Monitoring team manages reviews of platform transaction activity for potential red flag identification and regulatory reporting.
$90,000 - $137,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Consistently ranked as number one in the space, NICE Actimize experts apply innovative technology to protect institutions and safeguard consumers and investors assets by identifying financial crime, preventing fraud and providing regulatory compliance.
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Minimum Qualifications for this position as defined in the Minimum Qualifications for Faculty and Administrators in California Community Colleges published by the Academic Affairs Division, Chancellor's Office, California Community Colleges: Any bachelor's degree and two years of professional experience, or any associate degree and six years of professional experience.
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This role is perfect for someone with a deep understanding of SaaS and partnership ecosystem contracting, who finds success through relationship building and has a strong foundation in tech-related certification and regulatory areas (such as privacy, int’l corporate entities, policy upkeep and employment), with sensibility for establishing benefitting legal operations.
$131,000 - $230,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Senior Regulatory Affairs Specialist is responsible for developing strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain existing products, provide advice on regulatory requirements, prepare worldwide submissions, and negotiate their approval with global regulatory agencies.
$99,361 - $136,621 a yearFull-timeExpandApply NowActive JobUpdated Today
regulatory affairs jobs Title: sr Company: Csl Behring in Menlo Park, CA
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