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Partners with other functional leaders in CMC, Regulatory Affairs, Clinical Operations and Quality Assurance in support of the study project teams and ensures timely supply for clinical trials.
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The Senior Director is a highly visible role and will closely collaborate with cross-functional partners including Regulatory, Clinical Research, Clinical Operations, Biometrics, Medical Affairs, Patient Advocacy, and Commercial to successfully incorporate HEOR strategies and RWE to support the development and commercialization of Paltusotine.
$230,000 - $287,000 a yearFull-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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The Regulatory Affairs Sr. Director’s role leads regulatory strategy, regulatory filings and health authority interactions to support oncology products. This position will focus on nonclinical and clinical regulatory aspects of product development.
$242,000 - $285,000 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Responsible for the financial management of expenses and labor quality assurance/CQI regulatory affairs training and education of staff and development of an excellent customer service center.
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This is a newly created individual contributor position within the recently established Global Significant Remediation Oversight and Governance team as part of the Global Regulatory Affairs Office.
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Forms cross-functional alliances with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs, Quality Control and Manufacturing Operations by providing SMEs to these functions and project teams.
$221,170 - $286,220Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Manages appropriate levels of interface with Regulatory Affairs, Clinical, Quality, Marketing, Operations and Research & Development. Instills a sense of urgency to ensure goals are met in a timely manner while meeting regulatory, quality, and customer requirements.
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As part of this opportunity, the incumbent will work with functional groups including Regulatory Affairs, Quality Assurance, Marketing, Packaging and Manufacturing to develop requirements for labeling text.
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Our Medical Affairs function serves as a valued strategic partner with Clinical, Commercial, Regulatory, and Market Access on therapeutic solutions to support patients' needs. This position will report into the US Medical Immunology team which is a segment of the Medical Affairs Specialty Care organization.
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What You Can ExpectAs the Vice President, Government & Regulatory Affairs in Washington, DC you will be the primary representative for ENGIE North America’s interest before US legislators and regulators, regional transmission organization and independent system operators and their stakeholder processes, regional, and municipal government officials, and industry associations.
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Transamerica is organized by lines of business (Life Insurance, Annuities, Mutual Funds, Retirement Plans, and Employee Benefits), which are supported by Transamerica Corporate (Corporate Development; Finance; Internal Audit; Legislative, Regulatory & Policy; Office of the CEO; People and Places; Brand; Corporate Affairs; Risk; and Technology.
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Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial. Support CMC sections of major, complex regulatory submissions, including Investigation New Drugs (INDs), Investigational Medicinal Product Dossier (IMPD), New Drug Applications (NDAs), Marketing Authorization applications (MAAs), Quality Overall Summaries (QOS), and Biologics License Applications (BLAs.
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With minimal oversight, the Pr. Regulatory Affairs Specialist (PRA) for the European Union Medical Device Regulation (MDR) will be responsible for supporting execution to MDR compliance plans to ensure all applicable technical files (for devices ranging from class I to class III) meet the EU MDR requirements on schedule.
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Leading without authorityAble to effectively communicate on regulatory topics both internally and externallyShows flexibility and is open to adaptable to changeBS or equivalent with 10+ years of related experiencePrior regulatory affairs experience in major markets is expected#LI-RemoteThis position is remote.
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Partner with business affairs leadership to assist with contract and licensing workflows, risk management and other compliance matters related to vendor relations and project execution. Prepare routine payroll reconciliations and audits for management and regulatory agencies; including workers' comp audits.
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