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As a Barclays US Basel IV Regulatory Capital Reporting Assistant Vice President (AVP), you will be working in the Regulatory Capital Team and will be tasked with the development and on-going circulation and reporting of both point in time and Comprehensive Capital Analysis and Review (CCAR) Projected risk weighted assets (RWAs), capital leverage, and Single Counterparty Credit Limits (SCCL) Large Exposures for Barclays IHC (Intermediate Holding Company) to internal and external stakeholders.
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Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents) Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations Experience in drug development processes and post-approval requirements Experience in developing CMC regulatory strategy Experience in project management Have a solution-oriented approach to problem solving Ability to plan/prioritize work of group members and guide/develop others.
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At minimum 10 years' experience in the pharmaceutical industry in Biologics/Research & Development/Regulatory Affairs. Ensure strategic regional regulatory input which is in consideration of the commercial strategy and is provided into global regulatory teams and that the Regional Regulatory TA Team supports the Global Regulatory Affairs (GRA) vision of excellence, good scientific practice, integrity and compliance with regulatory standards.
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10+ years of industry experience and 7-10 years in Regulatory CMC.Direct experience with all types of CMC regulatory documents and sections (INDs, NDA, BLA, supplements, and responses) in eCTD format.
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Direct experience with all types of CMC regulatory documents and sections (INDs, NDA, BLA, supplements, and responses) in eCTD format. CMC regulatory compliance: Communicate and interpret new regulations or regulatory guidance and assess impact of changes.
$174,000 - $254,150 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience.
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Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents) Experience in developing CMC regulatory strategy. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.
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5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience. Responsible for the global regulatory evaluation of CMC change controls with supervision. 5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience.
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Monitor and stay abreast of relevant global, federal and state laws and regulations affecting the cloud services industry and ensure company compliance with applicable regulatory frameworks, including with respect to privacy and data protection, artificial intelligence, export controls, and sanctions.
$190,000 - $210,000 a yearFull-timeExpandUpdated 4 days ago - UpvoteDownvoteShare Job
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The position will provide legal support and guidance on product safety, regulatory compliance, and product liability matters. This position will provide legal support and guidance on regulatory compliance, product safety, and product liability matters.
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Strong experience with the contents and implementation of specific regulatory initiatives such as: Dodd-Frank, general consumer compliance, regulatory structure and organizations including the FRB, the CFPB, the OCC, the CFTC, FINRA, and the SEC.
$80,550 - $147,675 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Manage all vendors for regulatory activities, pharmacovigilance, state licensing, and compliance. The Associate Director of Regulatory Affairs & Compliance position at IBSA Pharma Inc. will have primary responsibility for the oversight and management of Regulatory matters related to IBSA commercial and development product portfolio.
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A career in Treasury Advisory, within Risk & Regulatory Advisory, will allow you to advise financial institutions on developing strategies to optimize financial performance and risk management across financial risks, including liquidity risk, market risk, counterparty credit risk and interest rate risk.
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This includes preparing and submitting regulatory submissions, such as 510(k) premarket clearances, De Novo Classifications and Premarket Approval (PMA) applications, and ensuring they contain accurate and complete information.
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ORGANIZATION STRUCTUREThe Senior Associate, Regulatory Operations/CMC reports into the Manager/ Director, Regulatory Affairs and is based in Morristown, New Jersey. Knowledge/experience with CMC regulatory requirements.
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Title: regulatory Company: Clarivate Plc in Whippany, NJ
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