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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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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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Collaborate with cross-functional teams including members from assay development, software engineering, marketing, quality, regulatory, and others to execute complex product development projects.
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The Principal Scientist, Computational Biology leads the development and deployment of computational methods for NGS-based clinical diagnostic assays in our clinical labs. The Principal Scientist, Computational Biology leads the development and deployment of computational methods for NGS-based clinical diagnostic assays in our clinical labs.
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Expertise in commercial healthcare and FDA regulatory law, specifically related to market access, pricing and price reporting, patient support, government contracting matters, and other laws and regulations related to the development and commercialization of pharmaceutical products.
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Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs.
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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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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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The Senior Epidemiologist will design methodologically-sound studies to meet project objectives and regulatory requirements, will collaborate on analytic tasks, and lead writing of protocols, study reports, and peer-reviewed publications, with oversight by senior staff as needed.
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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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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 Dorchester Center, MA
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