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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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Additionally, the VP, Regulatory Affairs and Quality will be responsible for hiring a Director, Regulatory Operations, to report to them. The Vice President, Regulatory Affairs and Quality will work collaboratively with colleagues across the company, and with outside partners, to design and execute global registrations strategies for all Xilio products, including initial regulatory efforts on pipeline programs.
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Investigate and document reports of non-compliance involving laboratory animal care and use, including preparation and submission of reports and other documents to the IACUC, IO, and regulatory and accrediting agencies when indicated.
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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. Maintain effective communication with internal and external stakeholders to ensure alignment and understanding of CMC regulatory strategies and requirements including change control.
$240,000 a yearFull-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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The Associate Director, Regulatory Affairs reports to the Senior Director, Regulatory Affairs and executes clinical and preclinical regulatory strategies and activities.
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As a pivotal leader within the Division of Student Affairs, the Director of Residence Life reports to the Senior Associate Dean of Students and oversees a large and multifaceted residential program.
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Emerson College, a premier global arts and communication institution with a foundation in the liberal arts, invites inquiries, nominations, and applications for its next Vice President for Student Affairs (VPSA.
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Reporting to the Chief Medical Officer, the Senior Manager of Regulatory Affairs will be responsible for the development and execution of Sails regulatory operations and the planning, managing and tracking of regulatory submissions.
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The primary role of the Director, Regulatory Affairs - CMC is to create and/or manage contributions from others for CMC regulatory submission documents. This position reports directly to the Senior Director, Head of Regulatory Affairs - CMC. The Director, Regulatory Affairs - CMC will be responsible and accountable for CMC submission documents while successfully up-holding the vision for the function and help mentoring junior team members.
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Significant in-house experience advising on data privacy, data protection and the legal and regulatory aspects of product development in the technology space (experience at a consumer-facing, Internet company preferred.
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The Business Partner will provide support to Pain Business Unit and Global and North America Medical Affairs colleagues and support OBIE Global, North America, and International Business Partners and key OBIE departmental initiatives, projects, and needs.
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Job DescriptionThe Talent Acquisition Leader, Medical Affairs CPEAO is an experienced full cycle Talent Acquisition expert who will provide sourcing strategies and programs to identified critical business needs for functions across the Medical Affairs organization within Vertex.
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FINRA Brokerage licenses Series 7 & 63 required within 6 months Optimizing the broker dealer clearing/correspondent client experience as it relates to ongoing regulatory reporting obligations Partnering with; Compliance partners to respond to regulatory examinations, including timely and accurate communications to regulator inquiries.
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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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May serve as regulatory affairs representative to provide input on clinical trials and filing activities and to ensure that report systems are maintained and compliant. This is a role intended for a forward looking, creative and agile regulatory strategist able to anticipate and address the challenges involved in developing and registering oncology therapeutics/vaccines based on messenger RNA technology, an unprecedented new drug modality in the US and other global markets.
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Title: regulatory affairs Company: Turnstone Biologics in Woburn, MA
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