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Position SummaryThis 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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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs – Pharmaceuticals. Join Takeda as a Senior Director, GRA - CMC Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team’s success in meeting goals/objectives.
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Interact with internal cross-functional teams, including Analytical Development, CMC, Supply Management, Regulatory Affairs, Program Management and Quality Assurance, as well as with Alpine's/Vertex network of external CMOs/contract labs to support company's clinical programs.
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Additionally, the VP, Regulatory Affairs and Quality will be responsible for hiring a Director, Regulatory Operations, to report to them. The Vice President, Regulatory Affairs and Quality will work collaboratively with colleagues across the company, and with outside partners, to design and execute global registrations strategies for all Xilio products, including initial regulatory efforts on pipeline programs.
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You will collaborate with colleagues in other functions including Study Physician, Patient Safety, Regulatory Affairs, Clinical Operations, Translational, CMC, and early development groups.
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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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Reporting to the VP of Program Strategy & Management, this person will work collaboratively to manage and integrate diverse R&D activities including but not limited to, preclinical research, clinical development, CMC, regulatory affairs, new product planning, business development and finance.
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Minimum of 10 years of experience in global regulatory affairs, with a focus on CMC, in the pharmaceutical or biotechnology industry. Maintain effective communication with internal and external stakeholders to ensure alignment and understanding of CMC regulatory strategies and requirements including change control.
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As a pivotal leader within the Division of Student Affairs, the Director of Residence Life reports to the Senior Associate Dean of Students and oversees a large and multifaceted residential program.
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Deep knowledge of Regulatory Affairs, FDA, and EU GMPs, particularly in relation to the development, manufacturing, and distribution of veterinary medicinal products. Collaborate closely with Product Development, Manufacturing Sciences & Technology, Regulatory Affairs, Site Quality (QA and QC), and both Internal and External Manufacturing teams to ensure quality integration.
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Collaborate with key stakeholders across the organization, including clinical operations, regulatory affairs, data management, and IT, to assess user needs, gather requirements, and develop tailored solutions to address business challenges.
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BS/BA degree in a relevant scientific discipline or MSc in Biology, Life Science, or related field with at least 5 years of relevant pharmaceutical/biotechnology industry experience, including at least 3 years of relevant Regulatory Affairs experience, or Advanced degree (PharmD, PhD, MD or DVM) with at least 2 years of regulatory or relevant pharmaceutical/biotechnology industry experience required.
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Works collaboratively with the Graduate Medical Education (GME) Office and Compliance as necessary to ensure the appropriate fiduciary and regulatory responsibility of education and training programs.
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The Associate Director, Regulatory Affairs reports to the Senior Director, Regulatory Affairs and executes clinical and preclinical regulatory strategies and activities.
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The Clinical Pharmacist Consultant is responsible for the evaluation and reporting of patient medication regimens, ensuring appropriateness, effectiveness, and safety, considering quality of life, adverse issues, cost and regulatory compliance.
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regulatory affairs jobs Title: assistant in Waltham, MA
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