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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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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.
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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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Sanofi is recruiting a new Global medical Director to support post- regulatory authorization clinical trial program for dupilumab in the Global respiratory Franchise for the respiratory indications including asthma and Chronic Obstructive Pulmonary Disease (COPD) for dupilumab and itep.
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The US Regulatory Affairs Sr. Associate – Wellness is responsible for end-to-end regulatory activities for the Wellness portfolio, which is comprised of primarily dietary supplements.
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Maintains laboratory records, archives, assay protocols and sample or specimen repository sufficient to pass regulatory oversight including CAP and FDA.7. Molecular biology experience; or either ASCP Molecular Biology (MB) or ASCP Medical Laboratory Scientist (MLS) eligible.
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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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Issue designs and support them through the project lifecycle including: design, drawing reviews, electromagnetic emissions analysis, and regulatory submissions (FCC and EME). Interface with project managers, real estate, construction, field operations, engineering, sales, marketing, finance and regulatory to ensure that our network quality and financial objectives are met.
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He/she 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 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 locations or contract manufacturing organizations (CMOs), or alliance partners.
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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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Works closely with quality, manufacturing, Global Regulatory Affairs (GRA), and technical staff from global locations within industrial network, contract manufacturing organizations (CMOs), and alliance partners to author high quality Module 2 and 3 regulatory submissions for both development and post-approval dossiers.
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The Sr. Director, Government Affairs (NJ)is responsible for overseeing state and local government, regulatory and public affairs for Altice USA. In coordination with Corporate Government Affairs, this position must develop and execute political, legislative and regulatory strategies and initiatives that support and enhance the company's business objectives, including strategic public affairs initiatives.
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CR Medicon is a fast-growing Contract Research Organization (CRO) and a platform providing customers with one-stop services for clinical studies of drugs and devices, including Regulatory Affairs, Medical Strategy, Medical Writing, Medical Monitoring, Pharmacovigilance, Clinical Operations, Data Management, Statistical Analysis and Bioanalytical Laboratory.
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Recruitment/Posting Title Coordinator, Faculty Personnel Administration Job Category Staff & Executive - Administrative & Support Department SPH-Office of Academic Affairs Overview. Rutgers is seeking a Coordinator, Faculty Personnel Administration for the Office Of Academic Affairs within the School of Public Health, located in Piscataway, NJ. The Coordinator, Faculty Personnel Administration will oversee daily operations of the Faculty Personnel Office to ensure proper procedures for faculty appointments, reappointments and promotions.
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Evaluate technical and regulatory requirements against business needs in development and maintenance of corporate level policies, procedures and strategies impacting all Ethicon, Inc sterile, single-use and reusable products, facilities and contractors.
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regulatory affairs jobs Title: sr regulatory affairs in Somerville, NJ
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