- AbbVie (North Chicago, IL)
- …Process Engineering, Drug Product Development (DPD), and Quality Assurance (QA) and CMC - Regulatory . Responsibilities: + Mentor analysts on the development of ... R&D) is a global analytical scientific organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products.… more
- Cardinal Health (Springfield, IL)
- … submissions within the discipline of chemistry, manufacturing, and controls ( CMC ). The _Sr. Coordinator, Regulatory Submissions Operations_ will use ... **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions Operations provides regulatory affairs and product… more
- AbbVie (North Chicago, IL)
- …functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams. + Authors scientific publications and present ... Pharmacology development plans and strategies that achieve commercial goals and regulatory requirements for multiple functions. Generates new PK/PD study proposals… more
- AbbVie (North Chicago, IL)
- …functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams. + Authors scientific publications and present ... Pharmacology development plans and strategies that achieve commercial goals and regulatory requirements for multiple functions. Generates new PK/PD study proposals… more
- Cardinal Health (Springfield, IL)
- …to Cardinal Health_** The _Scientist I, Chemistry, Manufacturing, and Control ( CMC )_ ensures efficient and quality production of product submission dossiers for ... Cardinal Health's Regulatory Science clients. Working remotely under the supervision of the CMC Supervisor, the Scientist I builds and formats Common Technical… more
- Astellas Pharma (Northbrook, IL)
- **Director CMC Development PRTL Packaging & Device US** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every ... packaging strategies and policies for the Americas. As a member of global CMC teams, this person will lead all aspects of package material selection, design,… more
- AbbVie (North Chicago, IL)
- …functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams. + Author scientific publications and present ... of expertise and critically evaluate relevant Clinical Pharmacology, PK/PD and regulatory advances and integrate this knowledge into research or development… more
- AbbVie (North Chicago, IL)
- …functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams. + Author scientific publications and present ... and critically evaluate relevant Pharmacometric, PK/PD, Clinical Pharmacology and regulatory advances and integrate this knowledge into Clinical Pharmacology… more
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- …disciplines involved in drug development including nonclinical pharmacology/toxicology, ADME, clinical, regulatory , and CMC . Work with formulation, biomarker and ... pre-IND, IND, phase1-3, **Pharmacokinetics** **(PK)** , **Pharmacokinetics-Pharmacodynamics (PK/PD)** and regulatory submissions. You will lead study design, execution and… more