- Takeda Pharmaceuticals (Boston, MA)
- …Proactively recognizes and contributes to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report to the Senior ... Director Global Regulatory Affairs CMC . **How you will contribute:** + Plan, execute and manage regulatory submissions for assigned compounds in various… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Senior Associate - Specialist, Global Regulatory Affairs CMC role is within in the GRA ... functions as follows: + With supervision, support the execution of regulatory CMC investigational, registration and post-approval strategies for assigned… more
- Actalent (Boston, MA)
- …Masters, PharmD, or PhD preferred. + Minimum of 8+ years of experience in CMC Regulatory Affairs for biologics, including IND activity, global CTAs, ... Job Title: Director Regulatory CMC Job Description We are seeking a creative and agile regulatory professional eager to join a collaborative team as a… 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 ... Research and Development. Sanofi's global regulatory affairs (GRA) function is comprised of more than 1800 people. The GRA Device Lead for Specialty Care… 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
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… 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 ... development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC ,...related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC , Marketing). + Minimum of 5… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Clinical Research and program management experience working with clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug ... IISR clinical trials in assigned TA. Ensure coordination with Pharmacovigilance and Regulatory Affairs to respond to external audits and requests from external … more
- AbbVie (Cambridge, MA)
- …of Drug Development (eg, pre-clinical research, clinical development, Regulatory Affairs , Chemistry Manufacturing and Controls ( CMC )). + Experience with ... conducting due diligence exercises within a scientific environment preferred. + Highly motivated professional with strong organizational and communication skills, excellent work ethic, and the ability to work independently as well as collaboratively in a team… more
- Sanofi Group (Cambridge, MA)
- …of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regional and global), in early and ... late stage, development of multiple modalities; experience within regulatory CMC not directly applicable. + Demonstrated experience with preparation of… more