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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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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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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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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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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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Preference will be given to students who have applied to and have been accepted into the Counselor Education – Student Affairs or Higher Education Administration program by the College of Graduate Studies application deadline.
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The Director will develop collaborative partnerships with the cross-functional Insmed team (Medical Affairs, HEOR, Clinical Development, Advocacy, Commercial and Market Access) as well as external medical experts and will have an integral role in driving the planning and execution of scientific communications deliverables across the Insmed respiratory franchise.
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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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Autoinjector/injectable launch experience a plusStrong understanding of the US pharmaceutical market, market dynamics, and regulatory environment. While primarily focused on self injector launch, this individual will also work on base product (vial and syringe) as needed including supporting performance management (both vial & syringe and self injector) as well as strategy and operations for the immunology portfolio.
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Arrange and prepare regulatory permit applications (NJDEP, USACE, NJSCD SESC) Experience and proficiency in developing regulatory permit applications. Support clients and regulatory personnel on projects.
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Monitor assay development, assay validation and sample analysis processes, ensure timely delivery of quality results in compliance with regulatory guidance." Must have Bioanalytical experience so they can help lab troubleshoot issues when applicable, Outsourcing experience preferred but the major focus/must haves should be at least 5 years (with masters or higher degree) or 10 years (with bachelors degree) bioanalytical experience, regulated experience, experience supporting clinical studies, biomarker ops or analysis.
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Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion. Strong business acumen and the ability to see business drivers outside of regulatory affairs.
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regulatory affairs jobs Company: Mallinckrodt Pharmaceuticals in Bridgewater, Beech-grove, Indiana
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