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Provide expert technical and consulting support, regarding OPWDD regulations, ACLD policies and procedures in regulatory affairs related programs and other complex related matters to the ACLD workforce.
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May oversee and direct the work of other Regulatory Affairs professionals. Serves as a regulatory liaison for new product development and make regulatory assessments of proposed changes to existing products for impact to regulatory documentation.
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Assist the Regulatory Affairs Manager with compliance-related inquiries and certifications as needed. The Regulatory Affairs (RA) Analyst is responsible for ensuring compliance of raw material documentation, finished product documentation, and finished product packaging with internal specifications and external regulatory requirements.
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Senior Director of Regulatory Affairs and Strategy will develop and implement comprehensive regulatory strategies and oversee daily regulatory affairs activities, including the areas of clinical research, CMC, regulatory operations, nonclinical study requirements, and regulatory compliance to support the successful development, approval, and marketing of Marengo products.
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Block is looking for an experienced policy and regulatory strategist to serve as our Head of Regulatory Affairs. Maintain fluency on a variety of regulatory and policy issues at the intersection of financial and technology policy, including financial regulation, consumer protection, tax, cryptocurrencies, AI/machine learning, intellectual property, and privacy.
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Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
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Plans, directs, and monitors regulatory affairs activities so that the organization has the permits, licences, certificates, authorizations, and other approvals it needs to conduct its current and future business activities; and produce, sell, and distribute its goods and services.
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The Regulatory Affairs Manager will play a vital role in supporting the product, marketing and management teams to stay informed with changes in the regulatory reporting market so they can perform their necessary functions.
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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD. Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
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Compensation for the Regulatory Affairs Specialist, Cell & Gene Therapy. Responsibilities of the Regulatory Affairs Specialist, Cell & Gene Therapy. Qualifications of the Regulatory Affairs Specialist, Cell & Gene Therapy.
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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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Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
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Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams. Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
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The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables.
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The Vice President of CMC Regulatory Affairs is leading the Ultragenyx's CMC Regulatory Affairs function. The role will report directly to Senior Vice President of Regulatory Affairs at Ultragenyx.
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regulatory job Title: regulatory affairs manager Company: Johnson
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