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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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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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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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Lead the execution and evolution of the integrated launch plan, coordinating with supply chain, regulatory affairs, market access, HEOR, medical affairs, and other functions. As a pivotal member of the rare disease team, the Global Marketing & Commercial Lead for Rare Disease will report to the General Manager and drive the execution of a robust commercial strategy for our portfolio, initially focusing on PA and MMA. This strategic role requires collaboration with multidisciplinary teams across R&D, Medical Affairs, Value and Access, and Supply Chain to ensure cohesive efforts within Moderna.
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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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The role functions in a company matrix team environment interacting with several key stakeholder groups including; Clinical Development, Pharmacovigilance, Regulatory Affairs, Quality Assurance, Manufacturing, Commercial, Medical Affairs, Research and Legal.
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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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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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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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Reporting to the Chief of Communications and Public Affairs, the Senior Director of Events will oversee the strategic planning and timely execution of events that reflect our new, community-centric strategic direction and contribute to our vision of advancing a region where access to financial well being is universal and prosperity is shared across race and ethnicity, and provide and special experiences for target audiences and affiliated marketing components.
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The Senior Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as vendors supporting Scholar Rock sponsored Clinical Studies.
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Collaborate with the Project Management and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs.
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Reporting to the VP of Program Strategy & Management, this person will work collaboratively to manage and integrate diverse R&D activities including but not limited to, preclinical research, clinical development, CMC, regulatory affairs, new product planning, business development and finance.
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Collaborate with key stakeholders across the organization, including clinical operations, regulatory affairs, data management, and IT, to assess user needs, gather requirements, and develop tailored solutions to address business challenges.
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PharmaLex is one of the largest worldwide providers of consulting services in the following focus areas: Quality Management & Compliance; Development Consulting & Scientific Affairs; Regulatory Affairs; and Pharmacovigilance, Epidemiology and Risk Management.
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regulatory affairs jobs Title: assistant Company: Citi in Boston, MA
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