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A scientific degree with directly relevant professional experience in small molecule product development, global CMC regulatory affairs, and CMC technical areas of at least 12 years with a BA/BS or 10 years with an MA/MS, PhD, PharmD, or MD.
$237,660 - $307,560Full-timeExpandApply NowActive JobUpdated 22 days 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 Today - 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.
$250Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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This role will include (i) drafting and negotiating various contracts and other legal documents in support of the Human Resources, Finance, Public Affairs, Government Affairs & Policy and Legal organizations (including the General Counsel’s Office) ; (ii) being the primary point of contact on legal contract issues for one or more client groups; and (iii) working closely with the Corporate Contracts Legal team to support other projects and work as needed.
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Requires Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Industrial Engineering Management, Regulatory Affairs, Regulatory Science, or related field and 7 years of progressive post-baccalaureate experience as a quality engineer, validation engineer or any quality assurance occupation in medical device or regulated industry.
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Duties: Serve as the System Manager for IT Systems enabling commercial and Medical Affairs business processes with technology platforms such as Veeva CRM, Commercial Data warehouse, Salesforce Marketing Cloud, Veeva PromoMats, Veeva MedComms, Case Management, Grant Management etc.
$150ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Collaborate with regulatory affairs to ensure compliance with applicable medical device regulations and standards throughout the development lifecycle. Define project requirements, specifications, and timelines in collaboration with cross-functional teams, including engineers, researchers, medical professionals, and regulatory specialists.
$200Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Reporting to the Clinical Research Manager of Blood & Marrow Transplantation and Cell Therapy (BMT-CT), the Clinical Research Coordinator Associate will be conversant in the goals, mission and priorities of the Institute, and utilize this knowledge to to manage data, enroll and follow patients on trial, and assist with regulatory and financial requirements of the trials.
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Privacy compliance strategy : Research, refine, and defend our regulatory compliance strategy; work with teams across the company to develop and implement risk mitigation plans. Transitioning to a leadership role such as General Manager, Managing Attorney, or Deputy General Counsel.
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You will collaborate closely with multiple teams across Process Development, Analytical Development, Regulatory Affairs, Quality and Manufacturing. You will collaborate closely with multiple teams across Process Development, Analytical Development, Regulatory Affairs, Quality and Manufacturing.
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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.
$144,000 - $162,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Liaise with other Legal Department colleagues, especially with the Product Regulatory legal team and the Data Privacy legal team to review and advise on regulatory issues regarding autonomous driving, MaaS, and TaaS.
$159,600 - $271,600 a yearFull-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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Ensure that each group has appropriate protocols to support tech transfer including process development, QA/QC, and regulatory. Experience interacting with government regulatory agencies is a plus (FDA, DEA, etc.
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Works closely with Office of Academic Affairs, Office of General Counsel, and other advisors on people issues; understands all aspects of faculty and staff labor relations. The Vice Chair/DFA provides strategic leadership and direction for all financial and administrative functions including budgeting and financial management, strategic planning, human resources, research administration, academic affairs, facilities/space, compliance, and safety.
$150ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience advising clients on global policy matters, new legislative and regulatory developments, and legal and policy advocacy options and strategies. You will report to Verkada’s Deputy General Counsel and Chief Privacy Officer and play a significant role in shaping the direction of the privacy and AI programs.
$200ExpandApply NowActive JobUpdated 2 days ago
regulatory affairs jobs Company: Delta Companies Inc in Foster City, CA
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