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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.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Establish relationships with peers in key functions including MAM, Asset Strategy Leads, Pipeline Commercial Strategy, HEOR, Market Analytics and Insights, US Pricing, International Market Access and US Government Affairs, US Public Affairs, and US Medical Affairs.
Full-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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The Director/Sr. Director, CMC Regulatory Affairs is responsible for development and lead of the CMC regulatory strategy for early-stage T-cell therapies. Represent CMC regulatory affairs on product teams and in health authority interactions.
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This is achieved by establishing and maintaining internal cross-functional collaborative relationships with internal stakeholders, including (1) R&D (Clinical Development/Regulatory/Medical Affairs/Epidemiology) (2) US, Area & Global Market Access/Global HTA (3) US, Area & Global Commercial (4) Global Commercial Development (5) Government Affairs.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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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 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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Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in Research and Development, Regulatory Affairs, and Clinical Development.
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Facilitates legislative and non-legislative relations between the IRS and Congress in conjunction with the National Director for Legislative Affairs. Manages, coordinates, and integrates legislative affairs with all IRS functional programs, Department of the Treasury, and other Administration offices.
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Job Number: R0196974 Intergovernmental Affairs Specialist. Experience in legislative affairs, policy , or lobbying. You'll serve as an Intergovernmental Affairs Spe cia list helping clients to develop stakeholder management strategies, research non-Health and Human Services ( HHS ) government agencies, identify key programs that relate to ARPH, and draft reports on e nga gements.
$60,400 - $137,000 a yearPart-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Working with the product leads, the Sr. Manager CMC Regulatory Affairs provides strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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CMC Regulatory Affairs, oncology, small molecule, drug development, clinical development. Director, CMC Regulatory Affairs. Serve as the PDM regulatory representative on project teams, provide CMC regulatory support for the clinical development of the investigational product(s), and ensure applicable regulatory requirements are appropriately met.
$100 - $113 an hourFull-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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The position is responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of pipeline compounds/products.
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Minimum 5 years in Regulatory Affairs within any of the following industries: pet food, food, OTC drugs, medical devices or pharmaceuticals; Create and foster a climate of teamwork and effective working relationships both within Regulatory Affairs and with our internal business partners: Quality, Marketing, Legal, New Product Innovation, Science & Technology, Professional Veterinary Affairs, Supply Chain, and others to achieve the synergy needed to effectively work as a team and promote the business.
$128,000 - $150,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Develop GIS maps for permitting, FERC licensing, and regulatory compliance deliverables as well as for marketing and business development efforts. Assist in developing permitting, FERC licensing, and regulatory compliance deliverables in accordance with defined scopes and schedules.
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Regulatory, Regulatory affairs, Fda, Regulatory documents, Regulatory submission, Quality assurance, Regulatory compliance, Gmp, Audit, Compliance, Labelling, food safety, food production, food science.
Full-timeExpandApply NowActive JobUpdated 10 days ago
affairs job Title: regulatory specialist Company: Abbvie
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