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The Living Therapeutics Initiative seeks a highly motivated Regulatory Affairs Senior Manager to manage the regulatory affairs, author and assemble IND applications, and help manage FIH studies advancing UCSF-developed cellular therapy candidates.
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We are seeking a regulatory affairs specialist to assist with ensuring regulatory compliance. The Regulatory Affairs team is highly cross-functional and work will center on collaborating with internal scientific, business and operational teams to address compliance needs of our novel probiotics and dietary supplements.
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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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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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6+ years of regulatory affairs experience in the biopharmaceutical industry or equivalent Pref Knowledge of regulatory requirements and early to mid-clinical stage experience with US regulatory submissions for therapeutic products (IND/BLA), including knowledge of the methods, tools, and practices involved with regulatory compliance.
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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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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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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.
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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.
$224,000 - $270,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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About the job Brand & PR Manager to CEO (Public Affairs/FinTech) Brand & PR Manager to CEO (Public Affairs/FinTech) Proven experience (5 years) in public relations, media relations, or corporate communications, preferably within the cryptocurrency or fintech industry.
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Partner with cross functional members across Gilead Pharmaceutical Development & Manufacturing (PDM), including Quality, Supply Chain, Manufacturing, Regulatory Affairs CMC, Finance and Technical Development to ensure successful commercialization of the late-stage portfolio, as well as on time delivery of clinical and commercial product.
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Reporting to the our CMC Executive Director, the CMC Regulatory Technical Writer, Associate Director/Director will be responsible for CMC technical document review and writing, authoring and compiling the CMC sections for global regulatory filings by working closely with the cross-functional teams including CMC, Quality, Clinical and Regulatory Affairs to ensure all CMC technical writing objectives are met.
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Reporting directly to the head of medical affairs, the Senior Director will play a pivotal role in leading the development and execution of strategies to generate and leverage real-world evidence to support the launch, development, market access, and commercialization of Aerovate's novel cardiopulmonary therapy.
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You will be a trusted advisor to senior management and provide guidance on a spectrum of regulatory matters at the enterprise level across all of our business units: Square, Cash App, TIDAL, TBD, Proto and Spiral.
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The Regulatory Manager will focus on monitoring and advocating for market policies that will advance the interests of RWECE within the Western interconnect. The Regulatory Manager is a key role within the RWE Clean Energy (RWECE) Regulatory Team working on Wholesale Markets in the West region.
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regulatory affairs specialist jobs in South San Francisco, CA
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