- AbbVie (North Chicago, IL)
- …. Job Description The Associate Director Regulatory Affairs , Chemistry, Manufacturing and Controls ( CMC ) works with internal and ... policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product development,… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …Collaborates with other external functions on CMC matters (eg, Quality, Commercial, Regulatory Affairs , etc.). Ensures the CMC function is adequately ... **Overview** The Director , CMC provides leadership for the...Xeris' commercial and clinical/late-stage products and projects. + Leads CMC Regulatory Submission support for US FDA… more
- Sumitomo Pharma (Springfield, IL)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of… more
- Sumitomo Pharma (Springfield, IL)
- …seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director Regulatory Affairs . The Associate Director is part ... of the Global Regulatory Affairs (GRA) team based in the US. He/she will...collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, clinical protocols/study reports,… more
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... **Associate Director , Small Molecule Analytical Development** + Lead and...and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols… more
- AbbVie (North Chicago, IL)
- …to use their broad understanding of Product Development, Manufacturing, Quality and Regulatory Affairs to translate the business objectives into actionable ... and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The ME&C Associate Director is a global program management expert responsible for managing major… more