- ASRC Industrial Services (Oak Ridge, TN)
- NDA Analyst - Engineer - Oak Ridge, TN Summary **Title:** NDA Analyst - Engineer - Oak Ridge, TN **ID:** 2252 - RSI - 02 Description _ASRC Industrial and its ... **Position Summary** RSI is actively seeking a Nondestructive Assay ( NDA ) Professional to support the NDA Program...Nondestructive Assay ( NDA ) Professional to support the NDA Program for the UCOR Cleanup Projects at Heritage… more
- Cleveland Clinic (Cleveland, OH)
- …for the ideal future caregiver include: + High School Diploma/GED + Basic Life Support (BLS) Certification through the American Heart Association (AHA) or American ... Join Cleveland Clinic's Lutheran Hospital where research and surgery are advanced, technology is leading-edge, patient care is world-class, and caregivers are family. Lutheran Hospital's Magnet status, the highest international recognition for excellence in… more
- Leidos (Annapolis Junction, MD)
- …**Leidos** has a new and exciting opportunity for a **Senior Linux Systems Administrator** in our **National Security Sector's (NSS) Cyber & Analytics Business Area ... (CABA)** . Our talented team is at the forefront in Security Engineering, Computer Network Operations (CNO), Mission Software, Analytical Methods and Modeling, Signals Intelligence (SIGINT), and Cryptographic Key Management. At **Leidos** , we offer… more
- Western Digital (Irvine, CA)
- …Western Digital's innovative technology and strategic partnerships through skilled NDA administration. This individual will also support attorneys and contract ... policies. + Escalating issues with NDAs to appropriate stakeholders. + Supporting NDA playbook updates or modifications and work to create and coordinate efficient… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …regulatory strategies for late-stage development, marketing applications (eg, NDA /MAA), and post-approval lifecycle activities (supplements, renewals, variations) ... Plan, prepare, and review CMC sections of regulatory submissions (IND/IMPD/ NDA /MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical… more
- Capgemini (New York, NY)
- …pharma and biotech clients, leading engagements on **submission readiness (IND/ NDA /BLA/MAA)** , **regulatory strategy** , **eCTD compilation/automation** , **CDISC ... . **Key Focus Areas** + **Regulatory Submissions & Strategy** : IND/ NDA /BLA/MAA pathways (traditional, 505(b)(2), accelerated, breakthrough). + **eCTD & CTD… more
- Sumitomo Pharma (Montgomery, AL)
- …in Oncology. In addition, the candidate must have recent Oncology NDA submission experience and submissions worldwide including HTA submissions. The individual ... all non-clinical and clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as… more
- Butler America (Washington, DC)
- …work. + Familiarity with and ability to work with SharePoint based tools for NDA request and approval workflow and NDA repository management. + May provide ... advice and guidance to internal stakeholders relative to acceptability of certain simple NDA provisions and make recommendations to IP legal, as may be required. +… more
- Taiho Oncology (Princeton, NJ)
- …regulatory integrity and completeness of all projects, supporting IND, CTA, NDA , MAA submissions. Performance Objectives: + Manage and support the preparation, ... submissions as assigned, including INDs and amendments, CTAs, marketing applications ( NDA /MAA), annual reports, safety reports, etc. + Support planning and executing… more
- AbbVie (Jersey City, NJ)
- …all patient safety activities, and will be leading the safety components of pre- NDA and NDA /sNDA submissions, regulatory responses, label and label updates, ... limited to, medical safety assessments, regulatory responses and risk management plans, NDA /sNDA submission - safety component + Apply current regulatory guidance as… more
- City of New York (New York, NY)
- …low-income communities it designates as Neighborhood Development Areas (NDAs). The NDA Initiative fosters community-level engagement to ensure that services address ... of each community. DYCD is seeking a Deputy Director to help lead its NDA Initiative portfolio. Under the supervision of the Director, with wide latitude for… more
- BeOne Medicines (Emeryville, CA)
- …expertise with advanced project management skills, driving successful NDA /BLA/MAA submissions and ensuring cross-functional integration across regions. The ... Management Excellence** + Lead and manage complex regulatory submissions (IND/CTA, NDA /BLA/MAA) across multiple regions, ensuring compliance with ICH, US, EU, China,… more
- BeOne Medicines (Emeryville, CA)
- …advanced project management and organizational leadership, driving successful NDA /BLA/MAA submissions and ensuring seamless cross-functional integration across ... Management Excellence** + Lead and manage complex regulatory submissions (IND/CTA, NDA /BLA/MAA) across multiple regions, ensuring compliance with ICH, US, EU, China,… more
- Bristol Myers Squibb (Princeton, NJ)
- …development programs through IND / clinical POC, and late stage development programs through NDA , BLA and MAA and post approval activities. The Director will play an ... (MIDD) approaches + Track record of regulatory interactions and deliverables, eg, IND, NDA , BLA and MAA filings. + In-depth knowledge of current practices and issues… more
- Sanofi Group (Cambridge, MA)
- …as designated. Leads submission team or regulatory sub-team to ensure NDA /BLA/MAA/Extensions filings meet the project timelines for product launch and is ... CMC not directly applicable. + Demonstrated experience with preparation of (s)BLA/(s) NDA /MAA, INDs/CTAs, HA meeting briefing documents and negotiating with a… more
- Taiho Oncology (Pleasanton, CA)
- …study protocols and clinical study reports (CSRs), investigator brochures, DSUR, NDA /MAA registration documents and publications. + Reviews and summarizes ongoing ... and final clinical study data, protocols and CSRs, investigator brochures, DSUR, NDA /MAA registration documents and publications. + Ability to critically review and… more
- Astellas Pharma (Northbrook, IL)
- …regulatory strategy input to assigned areas for submissions such as MAA, NDA and variations associated with early-stage development programs, development of new ... regulatory strategy into regulatory applications (ie Scientific Advice, IND, MAA, NDA , BLA and variations) across assigned development projects and/or commercial… more
- Takeda Pharmaceuticals (Boston, MA)
- …substance (and relevant drug product) CMC sections for global submissions (eg, IND/ NDA /MAA and annual reports) and supporting responses to health authority questions ... Demonstrated experience authoring CMC sections for regulatory submissions (eg, IND/IMPD/ NDA /MAA). + Proven SME-level experience working within quality systems… more
- Sumitomo Pharma (Indianapolis, IN)
- …(Stage 1,2, and 3) that supports phase appropriate development programs, NDA /BLA enabling validation programs and ongoing commercial manufacturing activities. + ... validation and transportation qualification/validation. + Plan, Design and execute major NDA /MAA enabling projects through sound DOE, early risk assessments and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …biostatistical analysis and reporting, document review and data inclusion for NDA submissions of assigned studies by collaborating with cross-functional partners to ... projects, including statistical analysis, document review, and data inclusion for NDA submissions by collaborating with other biostatistics team members and… more