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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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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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JOB DESCRIPTION Job TitleSr. Regulatory Affairs Specialist-CT/AMIJob DescriptionThe Senior RA Specialist will play a critical role in ensuring Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) solutions are safe, reliable, and compliant through driving global regulatory strategy and regulatory roadmaps—understanding competitive claim landscape, legislative initiatives, and marketing strategy.
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We are looking for a Director of Regulatory Reporting, a leadership position within the team that is responsible for ensuring the overall integrity of trade and position reporting submitted to the regulators for the Fidelity Broker-Dealers, National Financial and Fidelity Brokerage Services, as well as for correspondent client broker-dealer firms.
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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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Participate in CMC project team meetings and provide Regulatory CMC support as needed, including update to the teams on follow-up actions, information request, risk assessment and mitigation in support of clinical trial application and marketing application.
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Regulatory Affairs Manager III. 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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This 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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Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA to establish global submission activities and timelines in partnership with global and cross-functional stakeholders in Pharmaceutical Science, GMS, Biologics and Small Molecule operating units, Regulatory Affairs, and QA. Up to 20% domestic travel required.
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A Bachelor's degree required with a minimum of 4 years of regulatory affairs experience; or a Master's degree with a minimum of 3 years of regulatory affairs experience; or a Doctorate degree with a minimum of 1 year of regulatory affairs experience within the pharmaceutical/biotech industry.
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The Senior Director, Medical Affairs will be a leadership role, accountable for Medical Affairs strategy, Medical Excellence, and field team execution for Orchard’s investigational and approved hematopoietic stem cell - gene therapy (HSC-GT) clinical programs in North America (NA.
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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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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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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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Government relations or public affairs experience a plus. The Public Affairs & Communications Associate will be passionate about telling the Massachusetts Life Sciences Center's (MLSC) story and promoting our mission of supporting the growth and development of the life sciences in Massachusetts.
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Title: regulatory affairs Company: Turnstone Biologics in Waltham, MA
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