- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …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
- Merck (Rahway, NJ)
- …Familiarity with late-stage process development, process characterization, process validation regulatory submissions , and working with external contract ... Process Validation, Manufacturing Scale-Up, Mentorship, Process Improvements, Protein Purifications, Regulatory Submissions , Social Collaboration, Statistical Design of… more
- Deloitte (Morristown, NJ)
- …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
- Taiho Oncology (Princeton, NJ)
- …publication plan for scientific and clinical studies in process, prior to regulatory submissions , and assessment of secondary publication plan development and ... stakeholders (at all levels) to develop peer reviewed publications and submissions . Oversight of the lead Evidence and Value Development (EVD) publications… more
- Bristol Myers Squibb (Madison, NJ)
- …+ Proven track record in managing complex clinical programs leading to regulatory submissions + Deep understanding of Biology, targets and translational ... trials and will supervise and have accountability for the clinical components of regulatory filings + Will contribute to overall strategy for specific disease /… more
- Merck (Rahway, NJ)
- …and with external suppliers + Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs ... in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products. The incumbent must be able to… more
- J&J Family of Companies (Raritan, NJ)
- …biologics, or drugs is strongly preferred. + Experience in support of global regulatory submissions for medical devices, biologics or drugs is desirable ... customers and stakeholders (Key Opinion Leaders [KOLs], Surgeons, Health Regulatory Agencies, Professional Societies, etc.) to anticipate industry trends, understand… more
- Merck (Rahway, NJ)
- … Regulatory , Machine Learning, Multidisciplinary Collaboration, Multiple Therapeutic Areas, Regulatory Submissions **Job Posting End Date:** 08/2/2025 A job ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced… more
- Merck (Rahway, NJ)
- …and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Bristol Myers Squibb (Princeton, NJ)
- …areas: + Experience in drug development, authoring drug metabolism reports for regulatory submissions . + In-depth understanding of the principles, theories and ... and clinical pharmacology, Development DMPK plays a critical role in IND submissions and marketing authorization applications. We utilize our deep expertise in ADME… more
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