- 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
- Pfizer (Cambridge, MA)
- …Need (Minimum Requirements)** + BS is required. MS, PharmD, or PhD preferred + Prior clinical regulatory affairs experience in vaccines is required, at least ... to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Regulatory Affairs 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
- 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
- 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
- Sanofi Group (Cambridge, MA)
- …methodologies. + Collaborate with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, ... engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs ...collaborate with internal experts from Global and Local Medical, Clinical Development, and Regulatory teams to develop,… more
- Bausch + Lomb (Boston, MA)
- …members, other B&L departments (eg, R&D/Project Management, Clinical /Medical Affairs , Biometrics, Regulatory Affairs , Quality Assurance, ... and timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house team of CRAs, CTAs and/or CTMs… more
- Sanofi Group (Cambridge, MA)
- …collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug ... SOPs, GCP, ICH guidelines and other regulations + Review documents supporting clinical development such as Investigator's brochure, regulatory documents for… more