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Incredible opportunity to bring your experience leading CMC Regulatory strategies and your Biologics expertise to Parexel! D., Masters and Ph. D. preferably majoring in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology or Biology- RAC certification a plusExperience:- 7 years or more of CMC regulatory experience in the pharmaceutical industry with a history of successful of investigational filings and approvals of marketing applications as the CMC Regulatory lead.
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Two (2) years of progressively responsible experience in regulatory affairs, legislative affairs, or energy policy at an electric utility, regulatory agency, or legislative office. The Policy Advisor works under the direction of the Manager of Energy Policy, representing Central Coast Community Energy in various regulatory and compliance matters.
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As a Regulatory Analyst , you will work closely with the Senior Regulatory Advisor, develop compliance controls, and ensure adherence to ERCOT regulations. This role offers an opportunity for an experienced professional to leverage their expertise in the ERCOT power market and guide the organization on complex regulatory matters.
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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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Review, validate and approve regulatory label content and compliance documentation (i.e., supplier affidavits, 3rd party certificates, product lab test results) uploaded by suppliers into the Private Brands Product and Packaging Specification system for record-keeping and to substantiate on-package claims.
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The Senior Manager, CMC Regulatory Affairs is a hands-on and independent role requiring a strong individual who will provide strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls.
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This role primarily involves supporting Medicare, Medicare Advantage, and other value based care business initiatives as well as advising on general healthcare regulatory matters. We are looking for a Healthcare Regulatory counsel to join our Legal team.
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Author regulatory submissions and serve as a pharmacokinetics/clinical pharmacology subject matter expert during interactions with regulatory agencies. As a Pharmacokinetics/Clinical Pharmacology Principal Scientist, you will utilize your experience to further characterize the novel kinetics of our new therapeutic modality and build complex models that inform study designs and decision-making throughout the drug development process.
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Kyverna is seeking an experienced and passionate Associate Director, CMC Regulatory Affairs with a strong background in cell and gene therapy, preferably CAR T therapy. Minimum 3-5+ years of CMC Regulatory Affairs experience with direct experience in cell and gene therapy, preferably CAR T therapy.
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The Deputy Chief Ethics and Compliance Officer position is a senior-level executive role responsible for assisting in the oversight and management of an organization's compliance with laws, regulatory requirements, policies, and procedures.
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As the Director of Regulatory Compliance (MLRO), you will be working as part of Nium's global, dynamic Compliance team and will be reporting to the VP Compliance (US). Perform ongoing AML and OFAC risk assessments and horizon scanning for applicable regulatory requirements.
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The Regulatory Affairs Business Risk Officer is a first line professional within the Wholesale Banking division managing and assisting the business with regulatory adherence with a strong focus on BSA/AML, change management and people manager of a first line KYC team.
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Supporting the Head of U.S. Government and Regulatory Affairs and Head of the DC Office to develop and execute a Washington, DC public policy strategy with the U.S. Congress, U.S. Administration, and U.S. regulatory agencies.
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We are seeking an in-house lawyer with specialized experience advising on regulatory and statutory matters in the renewable energy (solar or battery storage) and /or EV charging space in the United States.
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Provide advice on best practices for development of a regulatory compliance program tailored to the company's solar, battery storage, and EV charging business lines. Research and provide guidance to internal teams on federal, state, local laws and industry legal standards governing the company's solar, battery storage and mobility / EV charging projects, including regulatory changes and their potential impact on products and services offered.
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regulatory job Title: principal Company: Parexel
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