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Investigate and document reports of non-compliance involving laboratory animal care and use, including preparation and submission of reports and other documents to the IACUC, IO, and regulatory and accrediting agencies when indicated.
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Ensures all appropriate CMC regulatory aspects across teams to support change control requests including transfer of supply within GSK or with a 3rd party are delivered to agreed timelines. Leads CMC regulatory activities for investigational, late development and/or early commercial GSK products.
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Serves as a key strategic partner representing Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to Biopharmaceutical, Pharma Supply Chain, Clinical Trial Supply, Quality Assurance, and Commercial interfaces on both global project and key strategic business initiatives.
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This is a role intended for a forward looking, creative and agile regulatory strategist able to anticipate and address the challenges involved in developing and registering oncology therapeutics/vaccines based on messenger RNA technology, an unprecedented new drug modality in the US and other global markets.
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The Executive Director, Regulatory Affairs will develop and execute global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease ensuring fast to market global product registrations, product promotion, maintenance of products and processes in regulatory compliance with local regulations.
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This role is crucial in ensuring that all CMC aspects of drug development meet regulatory requirements globally, supporting Scorpion Therapeutics' mission to bring transformative oncology therapies to patients.
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The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.
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Certified Regulatory Compliance Manager (CRCM) This position will serve as a member of the financial services client service team and be committed to regulatory compliance. 5 years or more of experience in financial institution regulatory compliance.
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Accountable for development and implementation of effective CMC regulatory strategies across products and product life cycles. Additionally, the VP, Regulatory Affairs and Quality will be responsible for hiring a Director, Regulatory Operations, to report to them.
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Leads nonclinical submission working groups to liaise effectively with cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory, Regulatory Operations, Drug Discovery Units, DMPK&M, and Drug Safety Research and Evaluation) to recognize aims, align on strategy, define executable timelines, and agree upon content for nonclinical regulatory submissions.
$170,500 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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You will work alongside a small team of ~5-7 other lawyers/paralegals supporting regulatory, corporate, transactional, and procurement matters and closely cooperate with other departments to deliver holistic and streamlined legal support to the U.S. RWE Offshore Wind business.
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Our client is looking to add a Regulatory Compliance Consultant that supports the provision of advisory services to assist financial institution clients to meet legal and regulatory responsibilities, including federal financial consumer protection laws, as well as Bank Secrecy Act/Anti-Money Laundering (BSA/AML) and Office of Foreign Assets Control (OFAC) requirements.
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Maintain effective communication with internal and external stakeholders to ensure alignment and understanding of CMC regulatory strategies and requirements including change control. In-depth knowledge of global CMC regulatory requirements and guidelines (FDA, EMA, ICH, etc.
$240,000 a yearFull-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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Reporting to the Chief Medical Officer, the Senior Manager of Regulatory Affairs will be responsible for the development and execution of Sails regulatory operations and the planning, managing and tracking of regulatory submissions.
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They are seeking a Vice President (or SVP) of Regulatory & Quality to build and lead both functions, and serve as the primary contact with FDA. Reporting into the CMO, you will provide crucial input on all regulatory matters related to the company’s development assets and lead interactions with Health Authorities.
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Title: regulatory Company: Gritstone Oncology in Waltham, MA
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