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NJ candidates: hybrid schedule (2x week) Boston candidates: in-person training, fully remote after •Education: minimum qualification is a Bachelors in Biology, or Pharmacy •Must-Have Experience with: VEEVA, life-cycle tools, MS Suite especially Word & Excel •Preferred experience: Regulatory affairs •Work Experience: 5 years of industry experience.
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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 performs life cycle management for marketed products by creating and/or evaluating change controls for global regulatory impact and planning corresponding variations/amendments/supplements.
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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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The CMC Regulatory Technical II Writer 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 clinical pharmacologist will be responsible and accountable for designing clinical pharmacology programs and studies, performing PK and PKPD data analysis, supporting clinical dose selection and authoring summary and regulatory submission documents.
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10+ years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC. Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products and Quality by Design approaches.
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Description SummaryThe Treasury Manager is responsible for cash management, cash flow forecasting, preparing, and executing monthly quarterly and daily intercompany funds flow schedule, foreign exchange management, monthly and quarterly reporting requirements for Treasurer, accounting, and external reporting and ad-hoc project work to support on-going business objectives and assist with debt compliance and capital allocation strategy.
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Interact with Regional Market Access/Health Economics / Outcomes Research and Medical Affairs teams to coordinate and develop real world evidence generation in support of their access programs.
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This role will develop and lead all medical affairs activities ensuring partnership within the team (medical strategy, scientific communications and publications) all key Medical Affairs functions (Medical Excellence, HEOR, Field Medical, Medical Information) as well as maintaining a high-level cross-functional collaboration across the organization to ensure alignment and One Insmed approach.
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Engage in scientific advice meetings with regulatory authorities (FDA, EMA, PMDA)Manage customized bioanalytical assays via network of external service providers in advance of and during clinical development.
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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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O Responsible for the development, implementation, and oversight of housing and helpline program policies and practices; ensuring that all are trauma- informed, equitable, and survivor centered to meet client needs, reflect organizational Core Values, and satisfy regulatory requirements.
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This role partners with the Key Account Manager/Associate Specialty Sales Executive - HCP Marketing Team, and Medical Affairs to execute against strategic imperatives and plans by brand. Our broad product portfolio includes renowned brands like Garden of Life®, Nature's Bounty®, Vital Proteins®, Orgain®, Nuun®, BOOST®, Carnation Breakfast Essentials®, Peptamen®, Compleat Organic Blends®, and more.
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Technical knowledge in maintenance/metrology management, broad understanding of facilities management, cGMP compliance, EHS and regulatory standards (e.g. EPA, OSHA, and DEA) Provides input in the development & execution strategy of calibrations (Cals), preventative maintenance (PM) & predictive maintenance (PDM) practices to ensure compliance (cGMP) with company policies and appropriate regulatory standards.
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Kelly® Science & Clinical is seeking a Regulatory Affairs Associate for 1 year contract position (with possibility of extension) position at a premier client in Skillman, NJ. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
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regulatory affairs jobs Company: Mallinckrodt Pharmaceuticals in Bridgewater, NJ
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