- Deloitte (Chicago, IL)
- …(ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA/EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years ... experience + 4+ years Life Sciences Chemistry, Manufacturing, and Controls ( CMC ) experience to include: + Introducing new technologies like GenAI, AI/ML,… more
- AbbVie (North Chicago, IL)
- …as analytical, process engineering, internal and external manufacturing, quality assurance, CMC regulatory affairs, supply chain and Operations Manufacturing ... is required. + Ability to influence internal and external experts on CMC regulatory issues, independently. + Demonstrated excellence in writing, presentation,… more
- AbbVie (North Chicago, IL)
- …Product Development, Molecular Profiling and Drug Delivery, Quality Assurance and CMC - Regulatory . Key Responsibilities: + The candidate will participate and/or ... R&D) is a global scientific organization responsible for all analytical CMC activities related to the development of AbbVie's pharmaceutical products. Our… more
- AbbVie (North Chicago, IL)
- …Process Engineering, Drug Product Development (DPD), and Quality Assurance (QA) and CMC - Regulatory . Responsibilities: + Manager a small team (3 direct reports) ... R&D) is a global analytical scientific organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products.… more
- AbbVie (North Chicago, IL)
- …initiatives among formulation development, analytical, clinical pharmacology and regulatory - CMC on biowaivers and biopharmaceutics risk assessment. ... directly support drug development programs. + Leads interactions with regulatory agencies in CMC development area and delivers regulatory filing packages… more
- AbbVie (North Chicago, IL)
- …Engineering, Drug Product Development (DPD), Quality Assurance (QA), and CMC - Regulatory . Responsibilities: + Utilize cutting-edge mass spectrometry techniques, ... in their area of expertise, critically evaluate relevant scientific and regulatory advances, and integrate this knowledge into research and development programs.… more
- AbbVie (North Chicago, IL)
- … regulatory queries, and participates in communications and meetings with regulatory agencies. Accountable for creating CMC development plan incl. timelines, ... high complexity utilizing a matrix approach. Leads Chemistry, Manufacturing and Controls ( CMC ) teams and Product Presentation and Device Strategy Teams (PPDST) of… 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
- 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
- Deloitte (Chicago, IL)
- …experience + 4+ years of experience in Life Sciences Pharmaceutical R&D regulatory domain. Experience to include: introducing new technologies like GenAI, AI/ML, and ... automation for pharmaceutical regulatory content or regulatory intelligence; Veeva RIM...generating submissions packages + Experience with submissions management, labeling, CMC change control and/or LCM processes + Understanding of… more