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Piper Companies is currently seeking a Regulatory Affairs Specialist, Gene & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies.
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Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
$51,824 - $63,600 a yearFull-timeRemoteExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Compensation for the Regulatory Affairs Specialist, Gene & Gene TherapySalary Range: Commensurate with experienceBenefits: Medical, Dental, Vision, 401k match, Paid Holidays, and PTO. Responsibilities of the Regulatory Affairs Specialist, Gene & Gene TherapyCoordinate and manage timing for regulatory submissions, collaborating with internal teams and stakeholders.
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Penn Carey Law’s Office of Global Engagement (formerly the Office of International Affairs) promotes, develops, and facilitates student engagement with international programming, including study abroad; global fellowships; conferences and research opportunities; student-lead projects; and promotion of global engagement.
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Essential Job Functions:Provides strategic advice on complex reporting and technological issues raised by the MRTS business units, Regulatory Services Management (“RSM”) team, Regulatory Operations teams, and other FINRA customers, as applicable.
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Communicate frequently with other Respiratory Sales Specialists across the country and cross-functional counterparts such as Marketing, Sales Ops, Market Access, Field Reimbursement, Training, and Medical Affairs to create alignment of business plan, focus on strategic drivers, and sharing best practices.
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Our department offers a wide range of programs, including a NASPAaccredited Master of Public Administration, an accelerated BA/MPA, an Executive MPA, an MS/PhD in Public Affairs, and a BA in Urban Studies and Community Development.
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Keywords: life sciences, PMP, project management, OnePagerPro, Smartsheet, Tableau, MS Project, cell therapy, deliverables, pharmaceuticals, CAR-T, biotechnology, health care, biology, chemistry, engineering, production, manufacturing science and technology, project pipeline, scope, CMC, chemistry manufacturing and controls, FDA, EMA, budgeting, supply chain, vendor management, CQA, CSM, regulatory compliance, tech transfer, therapeutic manufacturing, drug development.
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5 years working in risk and regulatory compliance within the banking, capital markets and/or insurance industries (including thorough knowledge of the Basel Accord, Dodd Frank, FBO, FINRA, SEC, FinCEN, OCC, FDIC, CCAR, etc.
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GEICO's Government and Regulatory Affairs team is looking for experienced Government Relations individuals to join our team to advance the Company's legislative and regulatory agenda.
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Our department offers a wide range of programs, including a NASPAA -accredited Master of Public Administration, an accelerated BA/ MPA , an Executive MPA , an MS/PhD in Public Affairs, and a BA in Urban Studies and Community Development.
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Our management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs and the development of manufacturing processes utilizing good manufacturing practices (GMPs.
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BSI Consulting Services is a trusted and agenda-shaping partner providing 'best practice' technical, regulatory, and business expertise and intelligence for our clients' most critical EHS, Supply Chain, and Digital risks and opportunities to achieve greater resilience, impact, and future-readiness.
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Deloitte Risk and Financial Advisory Risk, Data and Regulatory Liquidity - Senior Manager. Strong experience with the contents and implementation of specific regulatory initiatives such as: Dodd-Frank, general consumer compliance, regulatory structure and organizations including the FRB, the CFPB, the OCC, the CFTC, FINRA, and the SEC.
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Position Summary: Manages assigned aspects of the QAPI Program for Home Health to include compliance with Medicare Conditions of Participation (CoPs), and regulatory, and accreditation requirements.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Kelly in Philadelphia, PA
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