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Executive Office support: serves as Chief of Staff to the VP, Head of Alexion Regulatory Affairs, supporting internal and external engagement and managing activities as part of the function’s Executive Office.
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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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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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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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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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Familiarity with regulatory requirements and standards, such as FDA, GMP, and ISA. Certification in DeltaV or related control systems. Familiarity with regulatory requirements and standards, such as FDA, GMP, and ISA. Certification in DeltaV or related control systems.
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The primary role of the Director, Regulatory Affairs - CMC is to create and/or manage contributions from others for CMC regulatory submission documents. This position reports directly to the Senior Director, Head of Regulatory Affairs - CMC. The Director, Regulatory Affairs - CMC will be responsible and accountable for CMC submission documents while successfully up-holding the vision for the function and help mentoring junior team members.
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Certified Anti-Money Laundering Specialist (CAMS), Certified Internal Auditor (CIA), Certified Public Accountant (CPA), Certified Regulatory Compliance Manager (CRCM), or Certified Fraud Examiner (CFE.
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Requirements: Bachelor's degree in Biology, Chemistry, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements. Responsibilities are interchangeable within job titles of medical laboratory scientist (MLS), medical technologist or clinical laboratory scientist.
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Bachelor's degree in Biology, Chemistry, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements. Open to Medical Lab Technician [2 year MLT degree ] or Medical Lab Scientist / MedicalTechnologist [4 year BS.
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In collaboration with the Associate Chief Nurse, the Nursing Director plans, organizes, implements and oversees clinical and program development in the assigned area(s) to contribute to meeting the mission and goals of Brigham & Women’s Faulkner Hospital as well as the regulatory requirements of the JCAHO and other applicable federal, state and local regulatory or accrediting agencies.
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Skilled in writing and supporting the generation of regulatory documents related to Bioanalytical package (e.g. briefing book, assay description, CTD modules for IND/MAA etc) and regulatory interactions (e.g. with FDA CDRH, EU notified bodies.
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The Associate Director, Regulatory CMC executes multi-product global regulatory CMC strategies for cell therapy combination investigational and marketed products. Provides CMC regulatory guidance to cross-functional teams and key stakeholders.
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Extensive experience in assay development and proficiency in drug discovery and development, including delivering data and documentation supporting IND/CTA regulatory filings. Pioneering Medicines works with external strategic partners including Novo Nordisk, Pfizer, and the Cystic Fibrosis Foundation and continues to engage in discussions on potential partnerships.
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regulatory job Title: principal consultant in Watertown, MA
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