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The Senior Manager will function in a company matrix team environment interacting with several key stakeholder groups including; Pharmacovigilance, Clinical Development, Regulatory Affairs, Quality Assurance, Manufacturing, Commercial, Market Access, Medical Affairs, Research and Development, and Legal.
$157,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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8+ years relevant experience in quality control, quality assurance, and regulatory affairs at a Class I or Class II medical device manufacturer. Coordinate and organize test data and clinical or scientific reviews in support of regulatory submissions.
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This internship will provide you with a unique opportunity to gain experience in the field of regulatory affairs and learn firsthand the unique considerations for rare disease development.
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The ideal candidate should have a strong background in Regulatory Affairs CMC in a global pharmaceutical and/or biotechnology company with expertise in biologics, deep experience in product development and understanding of US, international regulations, and ICH guidelines related to biologics and cell therapy development.
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With a team of senior business lawyers with substantial in-house and general counsel experience, Outside GC provides private and public companies and non-profit organizations with outstanding corporate and IP legal services as needed at a fraction of the cost of either hiring a full-time general counsel or relying exclusively on law firm counsel.
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Associate Director, Public Affairs will serve as a critical Policy & Advocacy team member with responsibility for relations and collaboration with City and State legislators and regulators who make legislative, regulatory policy, and public policy decisions.
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Work closely with Global Patient Safety and Risk Management (GPSRM), Clinical Research, Regulatory Affairs, Clinical Operations, Biostatistics, and Medical Affairs to inform clinical development and real-world outcomes and answer product- and disease-area research questions for Alnylam RNAi therapeutics using observational studies, EMR/claims data, and RWE. The Senior Director, Epidemiology reports directly to the Senior Vice President, Data Science, Statistics, and Epidemiology.
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Ultragenyx is seeking a highly motivated Associate Director Regulatory Affairs CMC, who is inspired to be a compassionate leader in the field of drug development for rare disease patients.
$218,800 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Applicants must have at least (A) five (5) years of full-time or, equivalent part-time, professional, administrative, supervisory, or managerial experience in business administration, business management, public administration, public management, clinical administration or clinical management of which (B) at least one (1) year must have been in a project management, supervisory or managerial capacity or (C) any equivalent combination of the required experience and substitutions below.
$135,742.36 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Experience in providing regulatory CMC strategy for submission of clinical trial application (IMPD/IND) and marketing authorization application (NDA/MAA) for small molecule development compounds, including chemical drug, peptide and oligonucleotide.
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In addition to the Master's in Global Business Administration (GBA), the Fletcher School also offers Master's in Law & Diplomacy (MALD), a Master's in Global Affairs (MGA), a Master's in International Law (LLM), a Master's in International Business (MIB), a Global Master of Arts (GMAP), and a PhD.
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Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in various stages of development.
$266,200 a yearFull-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Acumen Pharmaceuticals is seeking a Director, CMC Regulatory, reporting to the Vice President, Regulatory Affairs, to lead the development, implementation, and execution of CMC regulatory strategy, including global submission strategy for investigational applications, clinical trial support, compliance, marketing application strategy, and CMC change management, ensuring compliance with global regulations (e.g., FDA, EMA, MHRA, HC, PMDA, CFDA, ANVISA.
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We're currently seeking a strong Regulatory Affairs Specialist, (RAS) who will work to ensure that company products and processes comply with all applicable regulations and standards.
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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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regulatory affairs specialist full time jobs in Boston, MA
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