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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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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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The Senior Regulatory Affairs Specialist is responsible for developing strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain existing products, provide advice on regulatory requirements, prepare worldwide submissions, and negotiate their approval with global regulatory agencies.
$99,361 - $136,621 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Director, CMC Regulatory Affairs – Biologics. Head of CMC Regulatory Affairs – Small Molecules. Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams.
$177,905 - $230,230Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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They will be responsible for strengthening awareness, affinity, and leadership of the Zoox brand, leading Media Relations, Public Affairs, Corporate Social Responsibility, Crisis Communications, Analyst Relations, and Event Activations.
$200,000 - $252,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The incumbent will report directly to Head of CMC Regulatory Affairs – Systems and Operations at Gilead. In addition, the Sr Director will be accountable for leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally.
$237,660 - $307,560Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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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.
$140,700 - $211,100 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Proven leader with a minimum of 15 years of experience in regulatory affairs and related technical documentation for complex medical devices including software, hardware, and disposable components.
$196,700 - $245,900 a yearFull-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Collaborate with cross functional teams including but not limited to Medicinal Chemistry, DMPK, Toxicology, QA, Analytical Development, Process R&D, Project Management and Regulatory to timely achieve project goals.
$160,000 - $200,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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We believe that our PCVs could receive regulatory approval based on successful completion of clinical studies utilizing well-defined surrogate immune endpoints, consistent with how other PCVs have obtained regulatory approval in the past, rather than requiring clinical field efficacy studies.
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Proficient in writing technical reports and AD/QC sections of CMC regulatory documents. Provide assistance with in-depth technical reviews for manufacturing and support global CMC regulatory submissions.
$178,000 - $218,000 a yearFull-timeExpandApply NowActive JobUpdated 4 months ago - UpvoteDownvoteShare Job
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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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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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regulatory affairs jobs Title: regulatory affairs assistant Company: Astrazeneca in San Mateo, CA
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