- Takeda Pharmaceuticals (Boston, MA)
- …to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory ... Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. You will be RA CMC member… more
- AbbVie (Waltham, MA)
- …. Job Description The Senior Manager 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
- Takeda Pharmaceuticals (Lexington, MA)
- …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as ... guide the team to define and drive strategy for CMC regulatory dossier content and reviews this...timely manner. Acts as an advisor and liaison to senior management. + As a member of the modality… 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
- 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 ... portfolio, including IND/CTAs, NDAs, NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership...of experience in regulatory affairs , focusing on regulatory … 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
- AbbVie (Cambridge, MA)
- …of Drug Development (eg, pre-clinical research, clinical development, Regulatory Affairs , Chemistry Manufacturing and Controls ( CMC )). + Experience with ... assessments of individual partnering opportunities to therapeutic area leadership and senior governance committees as well as contributing to Specialty and Discovery… more
- Takeda Pharmaceuticals (Boston, MA)
- …remote work allowed with 5 days/month onsite. **REQUIREMENTS:** Master's degree in Regulatory Affairs , Pharmacy, Biochemistry, Biology, or science related field ... following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Senior Research Associate **POSITION DESCRIPTION** : Takeda Development Center Americas,… more
- Sanofi Group (Cambridge, MA)
- …toward all GPT members, including eg project management, clinical operations, regulatory , safety, translational medicine, statistics, CMC , IA **Basic ... Global Project Head (GPH) is delegated various responsibilities by the Senior GPH and/orTherapeutic Area Head to provide leadership, supervision, and coordination… 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