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The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager's gene therapy products.
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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.
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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.
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We are seeking an Associate Director/Director, Regulatory Affairs, CMC to join our growing team. 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.
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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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Reporting to the Senior Vice President, Regulatory Affairs, the successful candidate will support the development of comprehensive regulatory strategies and collaborate with cross-functional teams to efficiently develop products in accordance with global regulations and guidelines.
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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 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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Associate Director, Global Regulatory Affairs, CMC Authoring (Remote) 5+ years of professional experience in global regulatory affairs CMC focusing on Biologics, Vaccines and/or Small Molecules.
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The Senior Manager 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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OPEN JOB: Pharma - Associate Director , US Advertising and Promotion , Global Regulatory Affairs - Hybrid. Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand and portfolio team review committees (RC), providing regulatory input into the review and approval of US advertising, promotion, disease-state, market access, and press materials.
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Position ResponsibilitiesThe Associate Director, Regulatory Affairs will develop and implement the regulatory strategy for an upcoming BLA submission, in alignment with company goals and FDA requirements.
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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.
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They are actively hiring a Senior Manager/Associate Director, Regulatory Affairs to act as the regulatory lead on multidisciplinary projects and clinical study teams, to provide input on documentation and procedural requirements defined by regulatory authorities.
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regulatory affairs jobs Title: regulatory affairs associate in Cambridge, MA
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