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The Sr Director, CMC Regulatory Affairs for Small Molecules is responsible for managing a team of professionals, who work with Gilead’s global portfolio of small molecule products in CMC Regulatory Affairs.
$237,660 - $307,560Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Working with the product leads, the Sr. Manager CMC Regulatory Affairs provides strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls.
ExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
ExpandApply NowActive JobUpdated 6 days ago - 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 - $307,560 a yearFull-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Gilead Sciences is seeking an experienced individual to join the Regulatory Affairs Vendor Governance team. Regulatory Affairs Vendor Governance is a function within the RA Business Operations group supporting all of Gilead RA's subfunctions.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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We are looking for an experienced Regulatory Affairs & Quality Assurance Lead to oversee our Mark I whole-body scanner regulatory submission and maintain market authorisation for our Gemini digital twin platform for compliance and commercial viability.
$160,000 - $200,000 a yearExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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The Senior Regulatory Affairs Specialist provides regulatory guidance to cross-functional teams; develops global regulatory strategies; advises on labeling and marketing materials for regulatory compliance; and evaluates product changes for impact on regulatory filings worldwide.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum’s gene therapy program/s. Manage the Regulatory Affairs (CMC) Strategy for Regulatory Affairs.
$200,000 - $270,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Director will work closely and collaboratively with the broader policy advocacy team and Government Affairs functions, and across Gilead departments with shared external relationships—including Public Affairs, Medical Affairs, and Commercial.
$201,025 - $260,150 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Collaborate with cross-functional departments (including Research, Pharmacology, DMPK, Translational Medicine & Clinical Pharmacology, CMC, Regulatory Affairs, Patient Safety and Pharmacovigilance) to implement discovery & development of toxicology strategies to enable the progression of optimized drug candidates and ensure that toxicological considerations are integrated into all stages of product development.
$225,000 - $260,000 a yearFull-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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We are seeking a driven, creative, collaborative, and highly respected individual who is passionate about public policy, government affairs, regulatory policy, helping patients, innovative science, biotechnology, and public health to serve as Vice President, Policy & Advocacy.
Starting at $250RemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This role is expected to closely collaborate with multiple teams across Process Development, MSAT, Analytical Development, Regulatory Affairs, Quality and Manufacturing. Author and review plans, protocols, technical reports and CMC sections of regulatory submissions.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Closely collaborates with various internal stakeholders such as Clinical Operations, Clinical Sciences, Regulatory Affairs, Biostatistics, Data Management, and Project Management, as well as external partners to ensure execution of pharmacovigilance activities in accordance with relevant regulatory requirements.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials.
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Associate Manager - Medical Affairs. The key functions of this role will be to collaborate with internal and external stakeholders including the Foster City Medical Affairs team, Scientific Publications, Medical Affairs Research, Marketing, Global Commercial Product Strategy, Value and Market Access, Clinical Research, Public Affairs, Government Affairs, Contracts/Finance, Pharmacology, Virology and Legal on both the global and regional levels.
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regulatory affairs jobs Title: sr regulatory associate Company: Thermo Fisher Scientific in San Carlos, CA
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