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Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop and maintain positive rapport and working relationships with other personnel in Regulatory Affairs, CMR, and other local and headquarter departments to accomplish company goals.
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This position is based in our Princeton, NJ office with onsite presence 60% of the time and reports to the Head of Regulatory Affairs. Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred.
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Regularly interfaces with team members in R&D including Biostatistics and SAS Programming staff, Data Management, clinical research and operations teams, regulatory affairs, clinical pharmacology, medical writing, medical affairs and quality management.
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QualificationsTo be considered for this role, you’ll require a minimum of 5 years of professional experience in relevant field of healthcare products or related activities e.g.:Work in medical devices industry and/or in vitro diagnostic devices(preferred) or closely related industries (e.g., pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs.
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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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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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Regulatory Affairs for early and late-stage assets in global drug development is required. the United States and Japan with strong understanding of regulatory authority processes and drug development is required.
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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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Demonstrates knowledge of safety, including any emerging safety concerns and risk/benefit profile for responsible compounds, as well as regulatory guidelines as they pertain to drug safety/pharmacovigilance.
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Expertise in R&D functions (e.g., Clinical Operations, CMC, Regulatory, Project management, Commercial) preferred. The Associate Director, Portfolio Management Insights, Portfolio & Strategic Operations (P&SO), drives portfolio management insights development and delivery to the Global Program Teams (GPTs), Therapeutics Areas (TAs) leaders, Hematology Oncology Cell Therapy (HOCT)/Immunology Cardiovascular Neuroscience (ICN) leadership, crucial for strategic decision-making within the drug development portfolio.
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Utilizes software systems, including Medicat, PeopleSoft, a BASICS Feedback Survey tool, and Microsoft Outlook and Excel, to manage referrals to and from BASICS as well as scheduling and the online assessment students complete as part of BASICSCollaborates closely with colleagues across University Health Services and from across campus, including the Office of the Dean of Undergraduate Students and Graduate Student Affairs, to receive referrals and educate campus partners about BASICS.
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Ensure the local HSE management system is effectively designed, implemented, and controlled and meets Firmenich standards, ISO standards, and all relevant regulatory requirements. Thorough knowledge of OSHA regulations and experience working with regulatory agencies.
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The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio.
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Janssen Research & Development , L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Senior Scientist, Regulatory CMC Dossier - Biotherapeutics based in Spring House, PA. Remote work options may be considered on a case-by-case basis and if approved by the Company.
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The Manager-Publications is expected to develop and utilize a network of internal relationships with local and global publication stakeholders, including colleagues from Medical Affairs, Clinical Data Science & Evidence, legal, regulatory affairs, global publication team, and commercial publications colleagues from market access and marketing.
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regulatory affairs jobs Title: sr affairs associate in Montgomery, NJ
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