Regulatory Submissions Jobs in China

(Senior) Director ToxicologyNingbo China (Onsite Relocation Supported)Salary: $120000-$180000Pharmaron is a leading global CRO delivering integrated solutions across drug discovery preclinical development and manufacturing. With a strong international footprint and continued growth we are expandin...

Job OverviewPerform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol applicable regulations and guidelines and sponsor requirements.Essential Functions Perform site monitoring visits (selection initiatio...

SUMMARY OF THE ROLEThe Bioanalysis and Translational Medicine department centers on datadriven bioanalysis and translational researchleveragingmolecular/protein assays cellular function and phenotyping and biomarker with PK/PD platforms to support cell therapy programs including CART and mRNALNP/len...

Job Overview:Primary contact with investigative sites during study maintenance and -when assigned- site startup activities with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within t...

Job Overview:Primary contact with investigative sites during study maintenance and -when assigned- site startup activities with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within t...

Job Overview:Site Navigators play a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as required. Serving as the single point of contact for investigative sites this role ensures smo...

Job Overview:Site Navigators play a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as required. Serving as the single point of contact for investigative sites this role ensures smo...

Job Overview:Site Navigators play a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as required. Serving as the single point of contact for investigative sites this role ensures smo...

Job Overview:Site Navigators play a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as required. Serving as the single point of contact for investigative sites this role ensures smo...

Work ScheduleStandard Office Hours (40/wk)Environmental ConditionsOfficeJob DescriptionJoin Us as a Principal Country Approval Specialist - Make an Impact at the Forefront of InnovationThe Principal Country Approval Specialist manages the preparation review and coordination of Country Submissions in...

Work ScheduleStandard Office Hours (40/wk)Environmental ConditionsOfficeJob DescriptionJoin Us as a Principal Country Approval Specialist - Make an Impact at the Forefront of InnovationThe Principal Country Approval Specialist manages the preparation review and coordination of Country Submissions in...

At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.A Day in the LifeResponsibilities may include the following an...

Job TitleClinical Development ScientistIGTJob DescriptionJob Responsibilities: Analyzes clinical trial protocols and studies ensuring adherence to regulatory requirements and alignment with strategic objectives providing recommendations for protocol optimization and enhancement. Crafts comprehensive...

Responsibilities:1Regulatory Submission Preparation & ExecutionLeadthe preparation review and compilation of high-quality regulatory dossiers (e.g. CTD/eCTD format) for product registrations variations renewals and other regulatory filings to NMPA and other global health authorities.Ensure accuracy...

Job Overview:Collaborate with peers across the organization to achieve client-centric delivery in a matrix organization. Collaboration across all stakeholders within Site Readiness. Oversight and accountability of Regulatory Authority (RA) Independent Review Board (IRB)/Ethics Committee (EC) and Thi...

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At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim...

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim...

Regulatory Reporting FRA Analyst Own and execute daily / monthly production of FR 2052a FRY14 FRY15 liquidity reports ensuring completeness accuracy and timeliness. Prepare and validate FDIC regulatory reports in compliance with 12 CFR 369 (FDIC reporting requirements) and 12 CFR 370 (recordkeeping...

Use Your Power for PurposeOur mission is straightforward: empower healthcare decisions regarding the safe and appropriate use of medicines for patients. Whether you are developing the framework to ensure our evidence is scientifically robust providing unbiased and medically essential expertise or ex...