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Regulatory reporting tools such as Axiom for financial reporting in banking. Data governance tools and their application in a regulatory banking context. Our Risk Data Management team helps our clients with leveraging data as a strategic asset for their risk, regulatory and compliance programs.
$240,488 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Initial draft authoring of scientific content for Common Technical Document (CTD) Quality sections and responses to health authority questions aligned with regulatory strategy for cell therapy clinical CMC regulatory submissions based on high quality technical reports.
$41.8 an hourExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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This individual will be responsible for delivering CMC documentation (Dossier and supporting documents) to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application.
Full-timeExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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Through scientific exchange, the MSL will communicate and advance the scientific platform aligned with the overall medical communications and medical affairs strategies. Attend medical/scientific meetings to represent Zealand Medical Affairs with KOLs and other HCPs, strengthen individual expertise as well as capture, integrate, and summarize information of strategic interest.
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He/she/they manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. He/she/they defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global Client locations or contract manufacturing organizations (CMOs), or alliance partners.
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Experience or having worked for a Federal or State regulatory or legislative body potentially including Congress, the FCC, a state legislature or a Governor’s office. Six years of relevant experience in corporate communications, public relations, cyber and corporate security, political campaign experience or crisis communications.
$202,000 a yearExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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The Clinical Systems Analyst will assist the Senior Director of Clinical and Development Systems in planning, directing, and coordinating software projects and support activities within the Drug Safety, Pharmacovigilance, Regulatory, Clinical Operations, and Quality Assurance groups.
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Experience in leading solutions around technology, data, Machine Learning, and Data Engineering, data governance and regulatory compliance, managing deliverables. Strong understanding of cloud infrastructure and services like EMR, Athena, Scala, Databricks, Snowflake, Spark, RDS, glue, Redshift, apache airflow, SQS, SNS.
ExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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The manger supports Bank responses to audit, model risk management and regulatory examinations and for all Credit Risk Stress Testing Activities and coordinates these activities with the Senior Director - Risk Analytics, the as well as the heads of Model Development, Model Implementation, and Capital Planning.
$217,000 a yearFull-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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The primary focus of the QA Specialist role will be to support routine clinical and commercial production to ensure consistent compliance with regulatory and industry expectations. Review and approve change control documentation that assesses and defines the scope, impact, risk, and regulatory impact associated with the change.
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Maintain effective working relationships with Development, Legal, Compliance, Regulatory, Pharmacovigilance, Marketing, and Medical colleagues and across regions. Will lead the strategic and tactical planning for relevant products, and represent Medical Affairs at various cross-functional team meetings.
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The Scientific Director for US Medical Affairs in CNS/Psychiatry provides specialist medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; evidence generation of clinical and scientific data e.g., therapeutic benefit, safety and medical value); educational initiatives ,scientific communications, and digital engagement.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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He/she/they defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global.
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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 Senior Statistical Analyst interfaces with key stakeholders (i.e. Statistics, Clinical Data Strategy & Operations, Medical Writing, Regulatory Publishing and Development Operations.) Fundamental understanding of the drug development process, including experience with regulatory filings.
Full-timeRemoteExpandApply NowActive JobUpdated 23 days ago
regulatory affairs jobs Company: Mallinckrodt Pharmaceuticals in Basking Ridge, NJ
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