- Cytel (Albany, NY)
- …the pre-specified timelines + Support the preparation of clinical study reports, regulatory submissions , publications, annual DSUR, and exploratory analyses + ... medical terminology, clinical trial methodologies, and FDA/ICH regulation + Experience supporting regulatory submissions , interacting with the FDA and/or global … more
- Lotte Biologics USA LLC (Syracuse, NY)
- …the appropriate statistical tools to address project objectives and/or support of regulatory submissions + Collaborate with functional groups including process ... and validations, as well as process and analytical validations in compliance with regulatory and ICH guidelines + Support creation of and leverage process data… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …interpersonal skills, analytical and problem-solving capabilities. + Have experience with regulatory submissions and clinical protocol development. + Can balance ... you will provide comprehensive leadership in engineering product management, regulatory compliance (design controls), and cross-functional collaboration with internal… more
- Haleon (Oak Hill, NY)
- …assist Site QO during regulatory inspections, fulfil request to support regulatory registration submissions and post approval CMC. Assure site adherence to ... FDA among other worldwide regulatory agencies. Approver of Complaint investigations and Annual Product...as requested by GMC or market RA to support submissions or renewals. + Support response to queries from… more
- WMCHealth (Valhalla, NY)
- …eligible providers and ensure accurate reporting for HRSA recertifications and regulatory submissions . Qualifications/Requirements: + Education: + Required: + ... Job Summary: The 340B Program Compliance Analyst is responsible for maintaining regulatory compliance within the 340B Program across all WMCHealth entities. This… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …pre-IND, IND, phase1-3, **Pharmacokinetics** **(PK)** , **Pharmacokinetics-Pharmacodynamics (PK/PD)** and regulatory submissions . You will lead study design, ... integrate them into clinical development plans to support drug development and regulatory packages **.** + Lead **clinical pharmacology** activities related to study… more
- Deloitte (New York, NY)
- …Q8, Q9, Q10), FDA/EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years experience leading, ... like GenAI, AI/ML, and automation for analytical methods, manufacturing, regulatory and/or QA/QC + Implementation of regulatory ...with CMC modules (Module 3 of CTD/eCTD) for global submissions , as well as familiarity with ICH guidelines (ie:… more
- Bassett Healthcare (Cooperstown, NY)
- …design teams, contractors, consultants, and internal stakeholders Help prepare and monitor regulatory submissions to agencies like NYSDOH, OMH, and OPWDD ... NFPA, OSHA, and ADA Maintain accurate documentation and participate in regulatory submissions Track budgeting, cost tracking, value engineering, project… more
- Amazon (New York, NY)
- …legal and risk analysis; drafting guidance documents, decision memos, regulatory submissions , and correspondence; managing internal data collection/review ... for counseling Amazon businesses on a broad range of regulatory and commercial matters, with a focus on global...provide advice to internal stakeholders, as well as develop submissions to regulators and other external stakeholders. Key job… more
- SMBC (New York, NY)
- …and validating stress loss scenarios, and reviewing stress testing outcomes and regulatory submissions to ensure alignment with supervisory expectations. + Drive ... Analytics Group, Model Risk Group, and the Operational & Regulatory Risk Group. The Credit Risk Group maintains sound...the firm's CCR framework with industry best practices and regulatory requirements. Serve as a subject matter expert on… more
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