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Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.
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Cross-functional collaboration/interaction with Clinical Affairs, R&D, Regulatory, Quality, OEC, Legal, Global Marketing & Commercial teams. Supporting the Director of Global Scientific Affairs, in conjunction with the Sr. Manager and Project Manager in Global Scientific Affairs, with KOL management as it relates to investigator-sponsored studies (ISS) and/or collaborative research studies (CRS.
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Reporting directly to the Sr. Director, Global Medical & Scientific Affairs (GMSA), Abbott Point of Care. Contribution to global Medical & Scientific Affairs strategy in conjunction with Directors of EMEA and APAC Medical Affairs.
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In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS-CMC senior manager will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.
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The Associate Director, Regulatory Operations role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs/Operations.
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Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations.
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The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group.
$190,625 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvote
Associate Director, Medical Affairs Cell Therapy, Franchise Strategy And Operations, Project Manager
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The Associate Director, Strategy and Operations is responsible for partnering with colleagues in Medical Affairs and in other functions including Commercial, both Heme and Cell Therapy to lead or support Strategic Planning responsibilities.
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Interacts internally with team representatives from PCOR, Finance, Brands, Medical Affairs, HEOR, Commercial Pipeline, Field Sales, Account Management, Analytics, Investor Relations, Value Communication and Contracting Strategy colleagues across all franchises, and all others, including global colleagues/counterparts, on a routine basis.
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The Sarbanes-Oxley (SOX) Control and Compliance Manager will lead the Company’s internal controls program, perform regulatory compliance audits as needed, and support the Company’s Environmental, Social and Governance (ESG) and Enterprise Risk Management (ERM) programs.
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We are looking for a Sanitation Manager interested in starting a SWEET career as part of our Sanitation team at PIM's Somerset Facilities in Somerset, NJ.JOB OVERVIEWThis position provides direction and leadership to sanitation & custodial employees to plan and execute the Master Sanitation Plan. Position will drive the strategy, development, implementation, and sustainability of the sanitation program to meet the regulatory and food safety requirements.
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Familiarity with genomics assay qualification/validation guidelines and guidance (FDA, CAP, CLIA, ACMG, NYSDOH, global regulatory requirements for assay development). Knowledge of clinical sample analysis regulatory and quality frameworks and guidance in the lab and at vendors (such as GCP, CLIA, CAP, and NYDOH.
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Knowledge of key concepts including unit operations, processes, quality by design (QbD), tech transfer, process validation, quality attributes, and regulatory milestones across pharma development.
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Works collaboratively with OPDC Vendors as well as the GPQ Department and other functional areas across Otsuka Affiliates and Subsidiaries to ensure compliance with local and global requirements and regulatory requirements.
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Collaborating with Medical Affairs colleagues and external vendors to execute asset strategy and tactical plans with appropriate use of resources and according to developed timelines. 10+ years experience in pharmaceutical industry Medical Affairs specifically.
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regulatory affairs jobs Title: pediatric Company: Maxim Healthcare Services in Monmouth Junction, NJ
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