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We are seeking an innovative and highly motivated Principal Scientist, Scientific Affairs who will contribute significantly to the development and continued growth of our advanced cell therapy manufacturing platform.
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Cross-functional Collaboration: Collaborate with cross-functional teams, including clinical development, regulatory affairs, market access, and commercial teams, to align medical affairs activities with clinical trial objectives, regulatory submissions, market access strategies, and commercialization plans.
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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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Develop and integrate timelines and budgets for clinical pharmacology activities with overall company timelines and goals, in close coordination with project management, clinical science, CMC, DMPK, nonclinical development, regulatory affairs and other stakeholders.
$262,000 - $321,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Provide assistance to the Assistant Dean for Student Affairs for large-scale events and programs, including new student Orientation, the Public Interest Law Foundation fundraising events, and Commencement.
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We’re a leader in staffing Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, HEOR, Market Access, and Sales & Marketing roles. Medical Science Liaison, Hematology/Oncology (Northern CA) TMAC (TMAC Direct) - San Francisco, CA, United States Tagged: MSL, Medical Affairs, Medical Science Liaison, Oncology, Hematology , Field Medical , Pharmaceutical, TMAC Direct Hire Hematology/Oncology MSL Expansion – Top BioPharma CompanyTMAC’s direct-hire service, formerly known as TMAC Direct, is an executive search firm and Pharma’s Complete Recruiting Resource.
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Safety Statisticians are part of collaborative, cross functional teams including members from Pharmacovigilance and Patient Safety and Epidemiology (e.g., product safety team physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs, and Medical Writing.
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Strong knowledge of pharmacokinetics and modeling, pharmacodynamic principles, ADME concepts, bioanalytical principles, regulatory guidelines and clinical pharmacology requirements in late stage clinical development.
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AA&PI Student Services is part of the Division of Equity & Community Inclusion under Student Affairs & Enrollment Management. Work in collaboration and partnership with other programs, departments, and areas within Student Affairs & Enrollment Management and in Academic Affairs to support Pacific Islander student needs for program planning, course advisement, major and career exploration.
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In the position of Regulatory Program Director in Roche / Genentech Pharma Technical Regulatory (PTR), you will be accountable for Health Authority interactions pertaining to CMC Information (i.e.: CMC information in an IND, IMPD and NDA/BLA/MAA filings), as well as informational and pre-submission meetings with global Health Authorities, partners and industry experts.
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5+ years experience in role/s operationalizing data policies - e.g. data privacy operations, privacy regulatory compliance, security GRC, Trust & Safety function - executing cross-functional organizational processes in data governance/ digital transformation.
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NAGPRA Registrar (9722C), Government & Community Affairs - 67034 About Berkeley At the University of California, Berkeley, we are committed to creating a community that fosters equity of experience and opportunity, and ensures that students, faculty, and staff of all backgrounds feel safe, welcome and included.
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Working in close partnership across various functions including Research, Bioanalytical Assay Department, Diagnostics, Clinical, Biostatistics, Computational Science, Regulatory and with external partners.
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Expert knowledge in cloud architecture, DevSecOps, vulnerability management, and familiarity with regulatory frameworks such as SOC, ISO, and FedRAMP. Solid background in governance, risk, and compliance, and extensive experience with security frameworks and privacy principles.
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Maintain regulatory compliance standards (examples: US Customs documents for all airline accounts, Occupational Safety and Health Administration (OSHA), etc. The ideal candidate will lead employees to ensure compliance with all safety, company, and regulatory procedures.
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regulatory affairs jobs Title: regulatory assistant Company: Astrazeneca in South San Francisco, CA
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