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Evaluate capital projects to determine commercial and regulatory requirements related to the commercialization, construction, operation, maintenance, and abandonment natural gas pipeline and storage facilities.
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You have experience with US regulatory affairs submissions such as 510(k) and/or PMA. You have at least 10 years of experience in this field so far in your career. You are a seasoned professional in the Regulatory Affairs space with specific experience with IVD and POC products.
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Associate Director, CMC Regulatory Affairs page is loaded. Associate Director, CMC Regulatory Affairs. The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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The Global Regulatory Affairs CMC & Device organization is responsible for global CMC regulatory strategies and activities for the PDT BU product portfolio through clinical development, market launch and product lifecycle management.
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Blackrock Neurotech, a leader in neurotechnology, is seeking an experienced and visionary Head of Regulatory Affairs to design and execute global regulatory strategies for our Brain-Computer Interface (BCI) platform technology and its applications.
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The Sarbanes-Oxley (SOX) Control and Compliance Manager will lead the Company’s internal controls program, perform regulatory compliance audits as needed, and support the Company’s Environmental, Social and Governance (ESG) and Enterprise Risk Management (ERM) programs.
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Minimum of 10 years of experience in global regulatory affairs, with a focus on CMC, in the pharmaceutical or biotechnology industry. 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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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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Macroeconomic and regulatory environment as they relate to financial institutions; A career in our Balance Sheet Management practice, within Financial Risk and Regulatory services, will provide you with the opportunity to help business leaders embed a proactive and dynamic risk management capability and mind set into their corporate business practices.
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You’ll help build tools that enable our clients to efficiently utilise capital and liquidity resources, consistent with regulatory expectations. To help us achieve this we have the PwC Professional; our global leadership development framework.
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Balance reporting requirements to multiple constituencies including; Centene Corporation regional vice president, state health plan president, chief operating officers and Corporate regulatory and government affairs staff.
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Exus is seeking a Regulatory and Compliance Specialist , who will be responsible for the interfacing, oversight and timely completion of all regulatory filings required under the US and Canadian standards for wind and solar generation facilities.
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The Regulatory Affairs Specialist will provide regulatory support for the Catalent Cell and Gene Therapy sites. This position will evaluate facility change controls for compliance with applicable change control guidance and will maintain site master files and Type V DMFs. In addition, the Regulatory Affairs Specialist will provide audit support and assist in preparing for group meetings and communications as appropriate.
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Collaborate with onshore teams and stakeholders to gather business requirements related to QMS functionalities, with a focus on Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
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The UPSIDE Foods Global Scientific & Regulatory Affairs (GSRA) team is hiring an Associate Director, Regulatory Operations to proactively create and build effective regulatory compliance operational capabilities.
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regulatory job Title: affairs specialist Company: Pwc
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