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0-3 years of experience in life science (pharmaceutical, biology, chemistry, bioinformatics) or engineering industry with a focus on information technology, clinical research, quality, regulatory affairs, manufacturing, or supply chain.
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The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRCMC) Devices and Combination Products will be responsible for leading, developing, and implementing global CMC regulatory strategy related to Alexion’s drug/device portfolio, in vitro diagnostics and clinical decision software leading to successful registration and life-cycle management of unique and technologically complex products.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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This position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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You will report to our Head of Regulatory Affairs and work side by side with your research and development colleagues to develop and execute innovative regulatory strategies for our development programs (from FIH through late-stage clinical programs), including the implementation of non-clinical and clinical regulatory strategy for relevant products.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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We are seeking an Associate Director/Director, Regulatory Affairs, CMC to join our growing team. Associate Director/Director, Regulatory Affairs, CMC. This position reports to the Senior Director, Regulatory Affairs, CMC and will be in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates.
$160,700 - $226,900 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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They are seeking a Regulatory Affairs Strategy Director or Associate Director who can develop and execute global regulatory strategy plans for their clinical-stage ophthalmology programs.
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A Bachelor’s, Master’s, or PhD in a scientific, medical, or regulatory discipline with 8+ years of experience in a Regulatory Affairs management function in a pharmaceutical, biotechnology, or related environment required.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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The Associate Director of Regulatory Affairs CMC will support development CMC team activities for an emerging portfolio of biologics products. Knowledge of CMC drug development process/requirements within pharmaceutical and/or biopharmaceutical industries and GMP requirements as it relates to regulatory requirements for assessing changes throughout 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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Reporting to the Sr. Director of Regulatory Affairs and Policy, this role will support and lead activities within the Regulatory group to advance development of the assets in Wave’s pipeline to registration and launch; will collaborate closely with team members within the group and across drug development disciplines such as CMC, Nonclinical, Clinical and Quality.
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The primary duty of the Associate Director, Regulatory Affairs is to support regulatory strategy for product development and manufacturing activities for the Cell & Gene Therapy sites to ensure compliance with GMP regulations and to support preparation and filing of regulatory submissions for clients.
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The Associate Director, Regulatory Affairs, will be responsible for day-to-day regulatory activities of early/late phase investigational products, leads the writing and submission of IND/CTA/amendments and future marketing application submissions, provides guidance to the team on regulatory filings and responses, and provides critical regulatory intelligence and guidance back to the team.
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We are seeking an Associate Director/Director of Regulatory Affairs to join the company. Bachelor's degree in Biological Sciences, Pharmacy or related field is required; Advanced degree or certificate in regulatory affairs is preferred.
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Associate Director, Regulatory Affairs - Boston, MA - Permanent. Demonstrated record of successful regulatory submissions (IND, CTA, NDA/MAA, etc). Plan and obtain regulatory designations including but not limited to breakthrough therapy designations, fast-track designations, and orphan drug designations.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Integrate knowledge of current legislation, guidelines, and other regulatory intelligence into the development strategies and ensure compliance with regulatory filing and reporting requirements.
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regulatory affairs jobs Title: regulatory affairs associate in Newton, MA
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