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10+ 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.
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A successful candidate will have a clinical background as an RN or LPN, in conjunction with direct experience in hospital auditing, joint commission, patient criteria knowledge, and hospital coding
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Primary responsibilities will be to provide support to a team of regulatory experts, scientists, and engineers to prepare hydropower licensing, permitting and compliance documents, perform consultation with agency and stakeholder groups, and support project management activities in accordance with Federal Energy Regulatory Commission (FERC) requirements.
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Regulatory Compliance : Support HEP’s ongoing compliance with federal, state and local regulations affecting the midstream oil and gas industry, including environmental and commercial regulatory compliance and coordinating outside regulatory counsel as necessary.
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Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
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The Associate Director, Regulatory Affairs will establish and grow internal CMC regulatory activities, providing strategic management and content plans to support Vyriad’s gene therapy product development, registration, and post-approval strategies.
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The position will be responsible for crafting and assuring development and execution of regulatory strategies for biological drug products and combination products globally, providing direction on the interpretation and application of global CMC regulations and guidance related to gene therapy.
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Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art class III cardiovascular medical devices. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.
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Senior Regulatory Affairs Specialist. Regulatory affairs experience in the medical device industry with a track record of successful submissions. Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance.
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You will advise on regulatory requirements as a key member of cross-functional teams, prepare and review FDA submissions, and interact with and respond to FDA pre-submission and during the review period.
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Provide regulatory support for currently marketed products as necessary to ensure ongoing compliance. Provide support for changes to existing products, including providing regulatory assessment of changes, and subsequent regulatory filings.
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As Legal Counsel/ Regulatory Counsel, you will work with the In-House Legal and Compliance teams, providing this reputable Fintech with banking/ financial services regulatory legal expertise and advice.
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CCRP - Cert Clin Research Prof (Preferred) or RAC - Regulatory Affairs Cert (Preferred) 2 Years experience in a regulatory role or 4 Years experience in related clinical research role (Required.
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Provide ongoing support to project teams for regulatory issues and questions. Interact and negotiate with regulatory agencies on defined matters as needed. Assist in the maintenance and improvement of regulatory SOPs.
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Global Regulatory Policy Manager – Liquidity covers a number of key aspects of prudential interpretation, including risk weighted assets (RWAs), capital resources, and the leverage ratio, across a full range of risk areas e.g. credit risk, counterparty credit risk, liquidity risk, securitisation, market risk, etc.
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Title: regulatory Company: Clarivate Plc
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