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You will work with our Head of Regulatory Affairs/Global Regulatory Lead and your research and development colleagues to develop and execute innovative regulatory strategies for our development programs, including supporting the implementation of non-clinical and clinical regulatory strategy for relevant products.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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Over 15 years of progressive advancement within global regulatory affairs in the pharmaceutical /biotech industry. The Vice President, Regulatory Affairs & Quality is in charge of providing subject matter expertise on all matters related to FDA and global regulatory requirements, as well as leading the growth and responsibilities of the regulatory and quality department.
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Skills: CMC, IND, Regulatory Affairs Operations, Submissions, ICH Regulations, GMP (Good Manufacturing Practice) At least 3-5 years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 3 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, or quality assurance/control or related technical field.
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The selected candidate will also work collaboratively with Quality Assurance to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.
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Understand, amplify with Onyx and integrate requirements from security and internal regulatory teams to ensure compliance with security policies and regulations as part of the governance products.
$153,000 - $207,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Collaborate closely with other departments such as clinical operations, technical operations/CMC, translational research and regulatory affairs to ensure alignment on program objectives. Contribute to the design and oversight of clinical trials, develop study protocols, case report forms, and informed consent documents, ensuring they are conducted in compliance with regulatory standards and ethical guidelines.
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Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression. Collaborate with regulatory affairs to support regulatory submissions and inspections.
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Familiarity with Applied Behavior Analysis and competency in the implementation of fundamental procedures as described in Epic’s training protocols and any regulatory or funder requirements (e.g., registered behavior technician training.
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Reporting to the SVP of Global Regulatory Affairs, the Sr. Director, Regulatory Affairs CMC will be responsible for developing and implementing regulatory CMC strategy leading to successful registration and life-cycle management of unique products serving patients with unmet medical needs.
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Review preclinical study reports, in conjunction with Pharmacokinetics/DMPK and prepare regulatory submission documentation. Author DMPK, nonclinical toxicology, and biomarker sections of regulatory documents.
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Support project team lead to author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Excellent technical writing skills with attention to detail in authoring methods, specifications, technical reports, and regulatory filing documents.
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Previous experience or exposure to regulatory, government, or external affairs. And our Water Quality companies-Aquatic Informatics, ChemTreat, Hach, McCrometer, OTT HydroMet, Sea-Bird Scientific, Trojan Technologies, and XOS-help customers manage, treat, purify, and protect the global water supply, from municipal and wastewater treatment facilities to lakes, rivers, watersheds, and oceans.
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Lead cross-functional teams comprised of members from diverse subject areas - including, but not limited to - clinical operations, medical, regulatory affairs, biometrics, safety, quality, and supply - to facilitate transparent communication and knowledge sharing.
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Lead scientific affairs activities, including preclinical information and establishing relationships with key KOLs. Responsible for all areas of preclinical research and development, including generating pharmacology and toxicology data, preclinical trial strategy and design, preparation of the preclinical development plan to support successful INDs, and contribution to regulatory strategy.
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regulatory affairs jobs Title: sr affairs associate in Lexington, MA
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