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This role collaborates cross-functionally with key cross-functional partners including other GMA functions, Clinical Development/Operations, Regulatory Affairs, Corporate Communications/IR, Legal, Market Access and Commercial, and Research.
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Drive awareness among Pfizer senior leaders of the value created / ROI from oncology development-focused AI/digital technological innovation, and work with Oncology Scientific Affairs and Strategic Partnerships colleagues on external communications on these topics.
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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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Work closely with NGS production, Quality and PreClinical Genotox for compliant execution of genotoxicity data packages in support of regulatory filings and clinical programs. Interact with Health Authorities, in writing and verbally, including pre-submission (e.g., pre-IND), scientific advice filings, IND or CTA, meeting briefing books, or other requests from global regulatory authorities.
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The Senior Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as vendors supporting Scholar Rock sponsored Clinical Studies.
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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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Collaborate with cross-functional teams, including Biology, Biologics, Clinical Operations, Clinical Development, and Regulatory Affairs functions, to align biomarker and CDx strategies with overall program objectives.
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And respond to regulatory inquiries related to DMPK, PK/PD, and clinical pharmacology. Determine scope, design, and planning and analysis of pharmacokinetic (PK) and pharmacodynamic (PD) studies, and modeling/simulations required from a drug development and regulatory perspective to take a project from concept to NDA submission.
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The Program Manager, Clinical Regulatory Compliance & Accreditation works directly with staff, management, and senior leadership to coordinate and perform day-to-day activities related to regulatory compliance across all Dana-Farber sites.
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Preferred Qualifications Experience working with legal counsel on regulatory and legislative affairs. The Virtual Power Plant Policy Director will lead SUN’s policy, regulatory, and advocacy efforts to implement solar + batteries Virtual Power Plant (VPP) policy across the country and in targeted states.
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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 the regulatory team to prepare and submit regulatory documents to health authorities, including INDs, NDAs, and BLAs. Collaborate with study team to prepare and complete clinical study reports, investigator's brochures.
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The impact you will make:Agios Pharmaceuticals is searching for a dynamic Senior Manager, Medical Writing to join our growing Regulatory Affairs & Medical Writing team. Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
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The Director reports to the Associate Dean of Student Equity and Inclusion, within Student Affairs. Master's degree in Higher Education and Student Affairs, International Education, or related field.
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Our department works closely with Analytical Development, Operations, Regulatory Affairs, and Quality control to formulate and manufacture innovative ocular formulations. Knowledge of current regulatory guidance and experience in managing IND/IMPD filing.
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regulatory affairs jobs Title: principal consultant in Lexington, MA
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