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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD. Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
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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.
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Work closely with the Head of Scientific Affairs & Strategic Partnerships and Scientific Affairs team to produce rapid, thoughtful responses to content-related requests from across Pfizer Oncology (CSO, Medical strategy, BoD, Investor Relations, colleagues, etc.
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Collaborate with cross functional teams including but not limited to Medicinal Chemistry, DMPK, Toxicology, QA, Pharmaceutical Development, Process R&D, Project Management and Regulatory to timely achieve project goals.
$135,000 - $175,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This person will oversee Medical Affairs including development of strategies and supporting execution for sub-functions (Strategy and Operations, Field Medical Affairs, Medical Communications and Publications, Patient Advocacy, health pharmacoeconomic and outcomes research (HEOR.
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Requirements:Advanced degree in life sciences in one or more of the following: MD, DO, PharmD, PhD, and 2+ years of relevant Medical Affairs (medical device/pharmaceutical industry), managed care, and HEOR experience, required.
$191,335 - $247,610Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Key functions outside CMC include Quality, Regulatory, Clinical, Safety, Corporate Program Management, Project Team Leaders, Toxicology, DMPK, Preclinical functions, Budgeting and Forecasting, IP, and others as organization evolves.
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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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Senior Regulatory Affairs Specialist, Redwood City, CA - Develop 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 approval with global regulatory agencies.
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Author/review and/or coach team members to author CMC regulatory sections of IND/INDa. Contribute to regulatory strategies and support associated agency interactions and product-related inspections.
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In-depth technical understanding of early and late-stage development of biologics products, including CMC Regulatory, Process/Analytical Development, and GMP Manufacturing and QC release and stability testing.
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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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Knowledge of state & federal OSHA, US Coast Guard regulations, PSMSC and other safety regulatory requirements for the maritime industry. The Company serves as stevedore and/or terminal operator for a wide variety of maritime cargoes for export and import.
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OPPORTUNITY Mammoth is hiring a Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.
$205,000 - $260,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Collaborate with cross functional teams (drug substance, drug product, supply chain, quality, CMC regulatory, CMC PM, Clinical, DMPK and tox, as well as program management) to ensure CMC and program goals are met.
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regulatory affairs jobs Title: sr Company: Csl Behring in Burlingame, CA
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