- Deloitte (Morristown, NJ)
- …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
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …development and ability to provide programming support and leadership for BLA and other regulatory submissions . + Experience in working on a submission to ... of statistical deliverables from a single study through to regulatory approval, product launch, and annual reports. The Senior...regulatory authorities. + Knowledge of regulatory requirements… more
- Sanofi Group (Morristown, NJ)
- …statistical concepts, techniques and clinical trial principles) and ability to lead regulatory submissions + Ability to collaborate with external partners (CROs, ... project, ensure technical validity, compliance to internal standards and SOPs, regulatory requirements + Plan and track programming project activities, timelines,… more
- IQVIA (Parsippany, NJ)
- …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
- IQVIA (Parsippany, NJ)
- …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
- Teva Pharmaceuticals (Parsippany, NJ)
- …scientific and business impact. + Experience in managing clinical trials and regulatory submissions . + Experience in leading and developing high performing, ... medical education, publications, and scientific communications. + Ensure compliance with regulatory requirements and ethical standards in all medical activities. +… more
- Astrix Technology (New Brunswick, NJ)
- …SDS-PAGE, ELISA, capillary electrophoresis, and cell-based assays.** + Familiarity with preparing regulatory submissions and data packages for interactions with ... + Ensure compliance with cGMP regulations, quality systems, and applicable ICH/ regulatory guidelines. + Participate in the investigation and documentation of… more
- Bristol Myers Squibb (Princeton, NJ)
- …and simulation plans * Collaborate on cross-functional drug development teams, regulatory submissions , and departmental **Experience Requirements** For Ph.D. or ... interactions and compiling technical documents that are critical for worldwide submissions . **Position Summary / Objective** * Responsible for design and execution… more
- Bristol Myers Squibb (Princeton, NJ)
- …pharmacokinetics activities of multiple projects; be responsible for preparation of regulatory dossier / submissions ; and assist in developing strategy ... safety and clinical pharmacology, Dev DMPK plays a critical role in IND submissions and marketing authorization applications. We utilize our deep expertise in ADME… more