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Represent Global Immunology through strong collaborations with project teams, project heads, and other colleagues in various intra and inter-departments (GAD, CMC, clinical, regulatory) to advance the viral respiratory vaccine candidates into clinical trials.
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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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We are accountable for enabling our programs in early research to reach development candidate nomination through regulatory filing and into clinical trials. How you will Achieve More with Intellia:Intellia is look for a Director, Genotoxicity Regulatory Lead to support the advancement of genome editing products into the clinic.
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10+ years of relevant regulatory/industry experience in biotech or pharmaceuticals with at least 8 years as the global Regulatory Affairs lead representative on project development teams that have led to marketing authorization.
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Proclinical is seeking a Director, Regulatory Affairs for a mid-sized oncology focused biotechnology company with their site in Massachusetts. Report to our Head of Regulatory Affairs and work side by side with your R&D colleagues to develop and execute innovative regulatory strategies for their development programs (from FIH through late-stage clinical programs), including the implementation of non-clinical and clinical regulatory strategy for relevant products.
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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.
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Present data at US Medical affairs events, including advisory boards and trainings as well as congresses & medical education events. Develop the US-relevant data generation strategy to address identified medical/scientific data gaps in close collaboration and alignment with US Immunology, Rheumatology, and Nephrology clinical experts, Global Medical, Clinical Development, Real World Evidence Generation teams and Research & Development.
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Understanding of banking regulatory hot topics, focus areas, and concepts, such as Fair Lending, Unfair or Deceptive Acts or Practices, Fraud Prevention, Capital and Liquidity Management, etc. As a Banking Compliance Risk Manager, you will get the opportunity to grow and contribute to our banking clients' business needs by providing in-depth technical knowledge on emerging regulations and help organizations leverage efficiencies within the Regulatory Compliance Practice – all with the resources, environment, and support to help you excel.
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Regulatory Affairs, Compliance and Legal. Develop and maintain effective relationships with key internal stakeholders including North American Medical Affairs, European Medical Affairs, Sanofi Emerging Market regional teams, and Established Products.
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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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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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This position supports three teams within Berklee Academic Affairs—faculty development, graduate studies, and institutional research and assessment—and contributes directly to a broad range of institutional functions including graduate student success, accreditation processes, and faculty and chair professional development offerings.
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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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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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Leads development and execution of multi-year global medical strategy for Neuroscience TA, appropriately aligned with overall GM strategy and cross-functional partners in R&D and GPD (Clinical, Regulatory, GEO, PV, GPLS, HEPA, MPD, and Regions.
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Title: regulatory affairs Company: Sanofi in Cambridge, MA
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