- Regeneron Pharmaceuticals (Tarrytown, NY)
- …documents (eg, Investigators' Brochure, protocol, study report, clinical components of regulatory submissions , safety related documents) produced by GCST + ... submission/approval of a clinical development program to support decision milestones and regulatory requirements. This role is a clinical subject matter expert for… more
- Deloitte (New York, NY)
- …available Preferred: + Understanding of pharmaceutical regulatory data and regulatory filing requirements and generating submissions packages + Experience ... experience + 4+ years of experience in Life Sciences Pharmaceutical R&D regulatory domain. Experience to include: introducing new technologies like GenAI, AI/ML, and… more
- JPMorgan Chase (New York, NY)
- …with line-of-business legal and compliance personnel on government investigations and regulatory matters + Draft correspondence and submissions , and interact ... quo and striving to be best-in-class. As a Government Investigations & Regulatory Enforcement Attorney - Vice President, Assistant General Counsel in our Government… more
- SMBC (New York, NY)
- …documentation and presentations for senior management, internal governance committees, and regulatory submissions . * Monitor changes in the risk landscape ... material risks across the enterprise to ensure alignment with CCAR regulatory expectations. The role involves close collaboration with business units, risk… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream ... processing. + Collaborate closely with Upstream MSAT, Validation MSAT, QA, Regulatory , Process Development, Analytical Development, and CDMO technical teams. + Stay… more
- IQVIA (New York, NY)
- …issues as appropriate. * Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form ... and close-out visits) in accordance with contracted scope of work and regulatory requirements, ie, Good Clinical Practice (GCP) and International Conference on… more
- ThermoFisher Scientific (East Syracuse, NY)
- …opportunities for technical advancements. * Support the preparation and review of regulatory submissions related to analytical procedures, method development and ... standards, extended characterization, and product stability/ shelf-life. * Support regulatory inspections, third-party audits, and customer audits through participating… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …all **pharmacometrics** activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions . You will conduct analysis, execution and reporting of ... + Author **pharmacometrics sections** of clinical pharmacology documents for regulatory filings including annual reports, investigator's brochure, IND/NDA applications… more
- Datavant (Albany, NY)
- …understand how Datavant's solutions can solve their challenges in clinical trials, regulatory submissions , and real-world data generation. **You Will:** + Serve ... retrieval, with expertise in real-world evidence, clinical trial operations, or regulatory data submission. + Excellent communication skills with the ability to… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream ... processing. + Collaborate closely with Downstream MSAT, Validation MSAT, QA, Regulatory , Process Development, and CDMO technical teams. + Stay current with… more
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