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Piper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies.
$40 - $55 an hourFull-timeExpandApply NowActive JobUpdated 30 days ago - UpvoteDownvoteShare Job
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SES is hiring an (Associate) Regulatory Counsel to support our Regulatory Affairs & Government team in the Legal Department. Support U.S. Universal Service Fund ("USF”) and similar international compliance, including training and advice to commercial sales and product teams on regulatory compliance with such obligations.
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Minimum seven (7) years customs brokerage, customs consulting, regulatory or similar professional services is required. Actively manage and continuously develop a team of compliance professionals providing day to day support of regulatory and compliance-based inquiries.
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Guides, directs and evaluates (1) Associate General Counsel, (3) Lease Administration Department (1) Senior Paralegals and, (2) Scientific & Regulatory Affairs Department. Provide guidance to Scientific and Regulatory Affairs on regulatory issues related to both product and procedures, including label safety, use of third party literature, and training documentation.
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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 - $77,716 a yearFull-timeRemoteExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Communicate regularly and effectively in a cross-functional matrix with development, origination, fundamentals, finance, and political & regulatory affairs staff to translate regulatory and market issues into business impacts and opportunities to benefit the position of Pattern's new and core business interests in MISO and other priority markets.
$103,000 - $139,000ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Cross-functional collaboration/interaction with Clinical Affairs, R&D, Regulatory, Quality, OEC, Legal, Global Marketing & Commercial teams. Supporting the Director of Global Scientific Affairs, in conjunction with the Sr. Manager and Project Manager in Global Scientific Affairs, with KOL management as it relates to investigator-sponsored studies (ISS) and/or collaborative research studies (CRS.
$250ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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Collaborate with cross-functional teams including biostatisticians, project management, clinical data managers, scientific affairs, medical affairs, and regulatory affairs to ensure timely and accurate delivery of statistical programming deliverables.
$150ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Provide practical and timely legal guidance on issues related to clinical, biometric, medical affairs, patient advocacy, regulatory affairs, pharmacovigilance, program and asset management, commercial development, pricing & reimbursement, sales, marketing, market access, patient services, and government affairs.
$150ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Support Patterns growth strategy through identification, analysis and assessment of regulatory and market affairs issues in MISO and other priority markets; Closely monitor, analyse, develop regulatory priorities and coordinate positions and strategies for regulatory and market affairs in MISO and other priority markets.
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What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated organizational leadership skills at both functional and enterprise levels.
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Develop the profile of the global Regulatory and IPMT practice group – this includes the practice areas of Antitrust and Competition; Communications, Internet, and Media; Energy Regulatory; Government Relations and Public Affairs; International Trade and Investment; Pharmaceuticals and Biotechnology Regulatory; and Privacy and Cybersecurity.
Full-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Reporting to the Vice President, Regulatory Affairs, the Senior Director, Regulatory Affairs – CMC will be responsible for leading, developing, and executing CMC regulatory strategies on programs ranging from early to late-stage development, including preparation and filing of IND and NDA/MAA submission.
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The Senior Director, Regulatory Affairs CMC will be responsible for planning and executing the CMC regulatory strategies for Celldexs therapeutic development programs. Industry experience of 10 years, of which at least 8 years spent in regulatory affairs with CMC responsibilities.
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regulatory affairs jobs Title: sales representative Company: Vector Marketing in AL, Arizona
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