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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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Support project teams, regulatory affairs, product management, marketing, and product stewardship in topics related to toxicology and kinetics. The position is located in Princeton, NJ and is part of the global Regulatory Affairs Toxicology Group.
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Ability to interact successfully with internal and external stakeholders including Clinical Development, Regulatory Affairs , Drug Safety and Pharmacovigilance, Legal , Commercial, Sales and Marketing, etc.
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Johnson & Johnson Innovative Medicine is recruiting for a Manager, CMC Regulatory Affairs to be located in Raritan, NJ; Titusville, NJ; or Beerse, Belgium. Ensures that CMC regulatory strategy is aligned with strategies of global regulatory Affairs, therapeutic areas and regional functions.
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EEB has many scholarly intersections the School for Public and International Affairs, Princeton Neuroscience Institute, Lewis Sigler Institute, and High Meadows Environmental Institute. Under the broad direction of the Chair, the Senior Manager of Finance and Administration, plans, oversees, and directs the administrative and financial affairs of the Department.
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Reporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical/Clinical Departments.
$200,000 - $280,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Duties: Draw on experience with statistical methodologies and data analysis methods; drug development and clinical trial design concept; statistical computing software such as R, and SAS; and project management to contribute to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions.
$145,000 - $170,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience working with cross-functional groups made up of two or more of the following: Market Access, Patient Support, Marketing, Sales, Medical Affairs, Market Research, or Finance. Associate Director, Market Access Marketing.
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Must be able to effective articulate and negotiate complex project related matters to FDA. Advanced understanding of pharmaceutical development and CMC regulatory affairs including regulatory guidelines, federal regulations and legal considerations.
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Expert knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs and Pharmacovigilance.
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The Vice President of Global Strategic Regulatory Operations (GRSO) reports directly to the Senior Vice President of Global Regulatory Safety and Biometrics (GRSB) and is a member of the GRSB Leadership Team. As such, this position has accountabilities for the sustained health, growth and continuous improvement of the GRSB organization, inclusive of developing effective partnerships with critical stakeholders across the BMS enterprise.
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Broad understanding of pharmaceutical development, Regulatory Affairs, Quality Assurance, Safety and Commercial. The Project Manager, Regulatory Affairs Global Compliance and Planning is responsible for driving implementation of and adherence to best practices in project management.
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Security and Governance: Implement security controls, access management policies, and data governance frameworks within Databricks to ensure data privacy, compliance, and regulatory requirements.
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Evaluate competitive landscape and various regulatory mechanisms that allow optimization of product development (e.g., orphan drug designation, breakthrough therapy designation, Fast Track, accelerated approval, pediatric plans) and present options and recommendations to expedite the path to market, as applicable.
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Author product statements and documentation in compliance with international and country specific legislation (e.g. product dossiers, registration certificates) with the support of the SDS authoring specialist for label data, GHS classifications, Dangerous Goods classifications, worker safety or environmental risk assessments and with the support of the Regulatory affairs team for site specifics and environmental regulation.
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regulatory affairs jobs Title: sr regulatory affairs associate in Montgomery, NJ
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