- Takeda Pharmaceuticals (Boston, MA)
- … Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Plan, execute and manage ... therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you...where you will oversee the development and execution of regulatory CMC development and registration strategies. You… more
- Actalent (Boston, MA)
- Job Title: Director Regulatory CMC Job...preferred. + Minimum of 8+ years of experience in CMC Regulatory Affairs for biologics, ... professional eager to join a collaborative team as a Director /Sr. Director of Regulatory CMC based in Boston with a hybrid option. This role involves… more
- Fresenius Medical Center (Waltham, MA)
- …(Advanced degree such as a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred. + **Experience:** + 12+ years ... into all stages of product development, including preclinical, clinical/medical, CMC , and post-market phases. + Monitor regulatory ...of experience in regulatory affairs , focusing on regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs . Advanced understanding in DMPK, ... Provides strategic scientific leadership and program management for multiple global CMC development teams dealing with complex development programs that require… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …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
- Takeda Pharmaceuticals (Lexington, MA)
- …and program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC , Marketing). + Minimum… more
- Sanofi Group (Cambridge, MA)
- …products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... **Job Title:** GRA Device Lead ( Director ) **Location** : Morristown, NJ, Cambridge, MA, Framingham,...Research and Development. Sanofi's global regulatory affairs (GRA) function is comprised of… more
- AbbVie (Worcester, MA)
- …Commercial, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs , R&D, and PDS&T to ensure alignment Responsibilities ... Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs , Research and Development. Additional Information Applicable… more
- AbbVie (Cambridge, MA)
- …of Drug Development (eg, pre-clinical research, clinical development, Regulatory Affairs , Chemistry Manufacturing and Controls ( CMC )). + Experience with ... an in-depth understanding of the science behind each of these opportunities. The Associate Director , Search & Evaluation will be a key member of the Specialty and… more