- Cipla (Fall River, MA)
- …is a plus. Experience Experience with product development process as applied to 505(b)(1) NDA and/or 505(b)(2) NDA and/or BLA product registration pathways is a ... must. Experience in handling complex injectable and Inhalation. Prior experience in managing projects with internal and/or external stakeholders (eg, CROs, CDMOs) is a must. Handling Green field project is plus. Experience with project governance practices is… more
- Insmed Incorporated (NJ)
- …for global regulatory documents (including but not limited to INDs/CTAs, NDA /BLAs, MAA, amendments annual reports) in alignment with established timelines, ... regulatory requirements, and internal quality standards Author and oversee the preparation of regulatory documents and meeting materials (eg, meeting requests, briefing books, cover letter forms, etc.) ensuring clarity, accuracy, and consistency Lead document… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …considerations.Proven track record of contributing to successful IND/CTA and BLA/ NDA filings.Strong understanding of FDA, EMA, and ICH regulations pertaining ... to toxicology and CGT development.Experience working with CROs and managing GLP-compliant study execution.Demonstrated leadership, communication, and organizational skills.Ability to translate complex scientific findings into clear, actionable recommendations… more
- Larimar Therapeutics (Philadelphia, PA)
- …based on knowledge of guidelines with practical experience (previous IND, CTA, NDA , BLA filings) to successfully achieve objectives for complex Larimar projects ... Provides detailed and forward-looking tactical advice to technical teams and stakeholders to achieve timely and efficient program submissions and approval, while ensuring compliance with applicable global regulatory requirements Evaluates proposed… more
- 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 ... Provides for patients' daily living activities; maintains safe and clean environment, maintains supplies, maintains equipment function. Transports patients and completes errands. With direction from RN assists in direct patient care tasks (ie performs EKGs,… 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
- 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
- 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
- System One (Florham Park, NJ)
- …Must have Module 5 expertise. + Must have regulatory strategy experience in IND/ NDA development, not just life cycle management. + Must have regulatory strategy ... experience in IND/ NDA development, not just life cycle management. Overview Support...in development (including 2 new IND applications and 1 NDA ) + Knowledge of and Compliance with FDA, EMEA,… 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
- Sumitomo Pharma (Little Rock, AR)
- …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
- 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
- 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
- Genentech (South San Francisco, CA)
- …properties of small molecule drug candidates from very early-stage research to NDA . We effectively collaborate in the development of safe and efficacious ... preclinical development studies, support clinical evaluation and contribute to IND and NDA filings. This internship position is located in **South San Francisco,… 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
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