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They will be responsible for coordinating submissions to local regulatory bodies including the Institutional Review Board (IRB) under the supervision of the Regulatory Affairs Manager.
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Assist Regulatory Affairs Manager with work request triage prior to weekly assignment distribution. The analyst works independently, under the direction of the Regulatory Affairs Manager, to.
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To do these effectively, the Analyst III – Policy & Regulatory Operations must have a demonstrated understanding of IEHP business operations and responsibilities of various departments in Health Services, Quality Systems, Provider Services, and Member Services; subject matter expertise of these departments’ policies and procedures and the regulations that drive their business operations and demonstrated ability to effectively and consistently manage multiple projects and priorities concurrently.
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The Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Regulatory Affairs Specialist.
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OPPORTUNITY Mammoth is hiring a Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.
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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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Reporting to the Director of Regulatory Affairs, the Senior RA Specialist will collaborate with global team members, cross-functional teams, and stakeholders. JOB DESCRIPTION Job TitlePrincipal Regulatory Affairs Specialist-CT/AMIJob DescriptionThe Principal RA Specialist will play a critical role in ensuring Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) solutions are safe, reliable, and compliant through driving global regulatory strategy and regulatory roadmaps—understanding competitive claim landscape, legislative initiatives, and marketing strategy.
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The Principal Scientist provides regional scientific and regulatory expertise and leverages scientific networks to enable the development and execution of Mars Wrigley (MW) Scientific and Regulatory Affairs (SRA) strategy.
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As the ASSOCIATE/DIRECTOR, COMPUTATIONAL CHEMISTRY, you will work as part of a multi-disciplinary team of Medicinal Chemists, Computational Chemists, Structural biologists, Pharmacologists and Biologists to provide Computational expertise to advance drug discovery projects.
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The Sr. Regulatory Specialist, LATAM will prepare and submit regulatory compliance documents with regulatory authorities, and advise on regulatory affairs that stem from the U.S. Company's activities in the Latin American (LATAM) region.
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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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Mammoth is hiring a Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.
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Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.
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Consult with senior management to develop and communicate regulatory strategies and advice for products and programs. Evaluate competitive landscape and various regulatory mechanisms that allow optimization of product development (e.g., orphan drug designation, breakthrough therapy designation, Fast Track, accelerated approval, pediatric plans) and present options and recommendations to expedite the path to market, as applicable.
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As assigned by management, provide regulatory due diligence assessment of licensing/acquisition opportunities. Prior experience of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA.
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Title: senior regulatory affairs Company: Biopharma Company
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