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What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD.Demonstrated organizational leadership skills at both functional and enterprise levels.
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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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Balance reporting requirements to multiple constituencies including; Centene Corporation regional vice president, state health plan president, chief operating officers and Corporate regulatory and government affairs staff.
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The Global Regulatory Affairs CMC & Device organization is responsible for global CMC regulatory strategies and activities for the PDT BU product portfolio through clinical development, market launch and product lifecycle management.
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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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You have experience with US regulatory affairs submissions such as 510(k) and/or PMA. You have at least 10 years of experience in this field so far in your career. You are a seasoned professional in the Regulatory Affairs space with specific experience with IVD and POC products.
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The Regulatory Affairs Business Risk Officer is a first line professional within the Wholesale Banking division managing and assisting the business with regulatory adherence with a strong focus on BSA/AML, change management and people manager of a first line KYC team.
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Associate Director, CMC Regulatory Affairs page is loaded. Associate Director, CMC Regulatory Affairs. The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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The UPSIDE Foods Global Scientific & Regulatory Affairs (GSRA) team is hiring an Associate Director, Regulatory Operations to proactively create and build effective regulatory compliance operational capabilities.
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Blackrock Neurotech, a leader in neurotechnology, is seeking an experienced and visionary Head of Regulatory Affairs to design and execute global regulatory strategies for our Brain-Computer Interface (BCI) platform technology and its applications.
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We want people to join our team in the role of External Affairs Coordinator with expertise in community outreach, marketing, and public relations. DCI Donor Services operates three organ procurement/tissue recovery organizations: New Mexico Donor Services, Sierra Donor Services, and Tennessee Donor Services.
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Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality metrics for site. Collaborates with USDA on regulatory compliance activities including regulatory approvals, import/export compliance, traceability, quarantine, safety testing and.
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This position is responsible for strategy and operations of the Norton Healthcare Pharmacy Enterprise for vendor contracting, inventory management processes, 340B compliance and optimization, and compliance with other applicable regulatory organizations and requirements.
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A minimum of 6-10 years’ experience in product stewardship, regulatory affairs, compliance, chemical consultancy, and/or risk assessment. The ideal candidate will have experience in chemical and environmental regulatory compliance, packaging regulatio ns, product stewardship and industrial risk management in the medical device or manufacturing industries.
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Collaborate with regulatory affairs and quality assurance teams to ensure compliance with submission guidelines and standards. Deep understanding of CDISC standards and regulatory submission requirements.
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regulatory affairs jobs Company: Clearancejobs in RI, Ohio
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