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Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
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Dragonfly Therapeutics is seeking a Senior Director, reporting directly to the Senior Vice President, Head of Regulatory Affairs, to join the regulatory team within our Regulatory Affairs organization.
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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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This will provide valuable insight into how regulatory affairs into the overall business strategy of the company. Intern may be asked to participate in team meetings and projects related to regulatory affairs.
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The Manager/Senior Manager of CMC Regulatory Affairs will be responsible for supporting commercial CMC and GMP activities for contracted manufactured products and Alkermes' European office.
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Strengthen internal gene therapy CMC capability by working with internal stakeholders and external partners to evaluate and enable gene therapy related GTP/GMP facilityLead 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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Regulatory Affairs Manager *PC Regulatory Affairs - Waltham MAAt Miltenyi Biotec, 3, employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies.
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O Provides communications between Global Regulatory Affairs CMC and partners within GRA and across and outside of the organization, as evidenced by the successful achievement of CMC regulatory milestones according to project plans, and by the level of partner satisfaction with the support provided by the group.
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2-5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a focus on regulatory operations. As the Regulatory Affairs Operations Specialist, Ad/Promo, you will play a pivotal role in ensuring regulatory compliance and operational efficiency within our organization.
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Skills: CMC, IND, Regulatory Affairs Operations, Submissions, ICH Regulations, GMP (Good Manufacturing Practice) At least 3-5 years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 3 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, or quality assurance/control or related technical field.
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You will work with our Head of Regulatory Affairs/Global Regulatory Lead and your research and development colleagues to develop and execute innovative regulatory strategies for our development programs, including supporting the implementation of non-clinical and clinical regulatory strategy for relevant products.
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We are currently seeking an experienced Machine Operator to join our team on second shift, which runs from 3:30 PM to 2:00 AM, Monday-Friday.
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BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience and at least twenty (20) years of progressively responsible experience in regulatory affairs within the biopharmaceutical industry, or equivalent.
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Over 15 years of progressive advancement within global regulatory affairs in the pharmaceutical /biotech industry. The Vice President, Regulatory Affairs & Quality is in charge of providing subject matter expertise on all matters related to FDA and global regulatory requirements, as well as leading the growth and responsibilities of the regulatory and quality department.
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This role partners with the Chief Regulatory Affairs Officer (CRAO) and Global Regulatory Program Leads to develop and execute a consolidated Regulatory development strategy to support company goals.
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regulatory affairs jobs Title: regulatory affairs in Lexington, MA
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