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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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In-depth knowledge of CMC regulatory requirements for Advanced Therapy Medicinal Products and have an understanding of current global and regional trends in CMC Regulatory Affairs for such products.
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Reports to: Global Regulatory Affairs Director. This Senior Regulatory Affairs Specialist will have an opportunity to work on new to market technology that is improving the field of diagnostic imaging and saving patient lives.
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Allogene is seeking a Senior Director, CMC Regulatory Affairs to provide support for products under development and lead CMC product strategy and provide regulatory direction to quality, manufacturing/tech ops and supply chain teams.
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We invested in new offices, sector teams and practice groups including investor engagement; shareholder activism; governance; regulatory and public affairs, including geopolitical; crisis; litigation; social issues including climate change and diversity, equity and inclusion; cybersecurity, data and privacy; employee engagement; digital communications; opinion research and analysis, and; creative services.
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The current role is for a Senior Director, Regulatory Affairs to join our team and advance our platform. The candidate should have a passion for working collaboratively with nonclinical, clinical and CMC team members to enable building regulatory strategies for CRISPR-based therapeutics.
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Practical experience in the pharmaceutical or biotech industry of at least five years in at least one major area of drug development, such as Discovery, Preclinical Development, Clinical Development, or Regulatory Affairs.
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The Director of Medical Affairs at Thermo Fisher Scientific will play a pivotal role in both strategically and functionally leading the North American (NA) Medical Affairs Team, undertaking the initiatives supporting the Clinical Sequencing Division (CSD) activities.
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These will include leadership of our work in media/PR, corporate branding, executive visibility and thought leadership, scientific communications, patient advocacy, public affairs with strong collaboration on investor relations as well as government and public affairs over time.
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We are seeking an experienced VP of Communications / External Affairs to build a communications strategy that highlights insitro's ground breaking science and how computational approaches can make a profound impact on drug discovery and development of new medicines for patients in need.
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Works collaboratively with vendors, Clinical Research, Drug Safety, Regulatory Affairs, Clinical Operation, and Project Management teams to meet project deliverables and timelines for statistical data analysis and reporting.
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In the position of Clinical Research Program Manager, you work under the supervision of the Director, and are responsible for overseeing study day-to-day activities, progress, and regulatory affairs.
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Additionally, the Sr. Director of Regulatory Operations owns the interface between Regulatory Operations vendors, including definition, planning, implementation of the collaboration, as well as day-to-day vendor oversight and budget management.
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Experience with clinical trials regulatory affairs, or related clinical trials experience such clinical research coordinator experience. Ensure that all investigators maintain the proper credentials and maintain these records in central regulatory binder (e.g. medical licenses, CVs, GCP/HSP certifications, NCI CTEP registration, SIP accounts, etc.
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Prepare and make submissions to IRB; prepare and maintain regulatory binders. Working knowledge of clinical trial design, clinical study operations, or regulatory approval process. The Protocol Project Manager (PPM) will work within a specified oncology disease program and serve as the main point of contact between the study team including faculty and clinical research coordinators (CRC), outside entities such as sponsors, and various departments within UCSF providing support.
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regulatory affairs jobs Title: sr director Company: Csl Behring in Brisbane, CA
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