- Takeda Pharmaceuticals (Boston, MA)
- …industry with direct leadership experience in at least one of the following: clinical development, pharmacovigilance, regulatory affairs or clinical ... tracking of required actions until completion + Monitor progress toward Global Regulatory Affairs KPIs, intervening as necessary to ensure that Regulatory is… more
- Beth Israel Lahey Health (Boston, MA)
- …Word, Excel, PowerPoint or Access. **Preferred Qualifications:** + 1-3 years of clinical trial regulatory affairs experience preferred. **Competencies:** ... in people's lives.** The Regulatory Specialist supports regulatory compliance for clinical research at Beth...Qualifications:** + Bachelor's degree required; Master's degree preferred in Regulatory Affairs . + 1-3 years related work… more
- Sanofi Group (Cambridge, MA)
- …The Associate Director collaborates closely with cross-functional teams, including Global Regulatory Affairs , Clinical Development, Safety, and Medical ... **Job Title:** Associate Director, Global Regulatory Affairs - Global Labeling Strategy...Associate Director contributes to early development activities by providing regulatory input into clinical development plans, including… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …(T0 - T1) or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs , or Clinical Development is preferred. + Minimum of 7+ ... value and real-world evidence, US and global commercial teams, market access, and regulatory affairs , to ensure integrated global strategies and cohesive medical… more
- Takeda Pharmaceuticals (Boston, MA)
- …technical product strategy across Takeda's development technology portfolio, encompassing Clinical Development, Regulatory Affairs , and Pharmacovigilance ... Global Development Technologies (CTMS, EDC, eTMF, IRT, eCOA, DCT solutions). Regulatory Affairs Technologies (RIM systems, publishing tools, global submission… more
- Sanofi Group (Cambridge, MA)
- …+ Provide regulatory labeling leadership to cross-functional teams ( Regulatory Strategy, Clinical Development, Medical Affairs , Pharmacovigilance, ... **Job Title:** Director, Global Regulatory Affairs - Global Labeling Strategy...shaping labeling strategy early in product development by providing regulatory input into clinical development plans, including… more
- Sanofi Group (Cambridge, MA)
- …discipline, PharmD, or medically qualified with: + Min 15 years of experience working in clinical development and/or regulatory affairs + Min 10 years of ... **Job Title:** Clinical Documentation Global Head **Location** : Cambridge, MA,...revenues by expediting submission timelines and facilitating reviews by regulatory agencies of sanofi key assets. + He/she: Creates… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …through close collaboration with cross-functional teams (including Medical Affairs , Clinical Development, Regulatory Affairs , Commercial, GPD comms), to ... Expertise:** + Comprehensive understanding of the pharmaceutical industry and medical affairs + Global regulatory expertise with demonstrated strong ability… more
- Danaher Corporation (Boston, MA)
- …digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work ... m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal, Regulatory Affairs is responsible for regulatory… more
- Sumitomo Pharma (Boston, MA)
- …for Oncology clinical development activities. + Partner with Translational Research, Regulatory Affairs , Clinical Operations, and Medical Affairs ... (including Clinical Operations), Biometrics, Regulatory , Early Clinical Development, Pre- clinical research, Medical Affairs and Commercial… more