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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 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.
$90,000 - $210,000 a yearFull-timeExpandApply NowActive JobUpdated Today - 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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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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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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Establish appropriate strategic partnerships with internal leaders in clinical development, regulatory affairs, safety, operations, research, and commercial. Collaborate with legal, compliance, and regulatory authorities to ensure proper and ethical interactions between medical affairs personnel and external stakeholders.
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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 22 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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Collaborate with clinical development and medical affairs to develop plans for publication of diagnostic test results in identifying biomarker-positive patient populations. Collaborate closely with diagnostic partners and internal functions, including biostatistics, data management, medical writing, regulatory, and project management to enable regulatory submissions to support CDx approvals.
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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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5+ years experience in Communications, Public Relations, Public Affairs. We're looking for an experienced professional with experience in media training, external speaking, and content development (i.e. op-eds, keynote presentations, videos, bylines), as well as a deep interest in AI and how it will impact business, public policy, and culture.
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The Executive Director of Community and Government Relations reports to the Chancellor and will manage public affairs, government, media, and community relations, oversee employee housing, district committee coordination, county-wide strategic initiatives and partnerships, and other duties as assigned.
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Minimum of 7 years of experience in external affairs, advocacy, government relations, or related roles, preferably within the technology or financial services industry. Public Affairs: Represent &/or support others’ participation at events, conferences, and other forums to build relationships, foster awareness and trust in the platform and our team, and advance our programmatic and business goals.
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This position sits in the Real World Evidence (RWE) team within Medical Affairs and reports into the Head of RWE. This role requires a hybrid skill set between clinical research, clinical data management, working with healthcare providers, and understanding the oncology space.
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This role reports to the Associate Director, Business Intelligence and will work closely with cross-functional teams, including Sales, Marketing, Market Access, Medical Affairs, Compliance, Global Technical Services (GTS), Business Planning, and GTS organizations.
$136,000 - $181,000 a yearExpandApply NowActive JobUpdated Today
affairs job Title: regulatory specialist Company: Parexel in San Mateo, CA
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