- 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 (Boston, MA)
- …probabilities of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices and… more
- Merck (Boston, MA)
- **Job Description** The Executive Director (ED) for US Medical Affairs (USMA) understands Our Company's enterprise level strategies and leads cross-functionally ... with the Global Medical and Scientific Affairs Therapeutic Area (GMSA TA) teams to translate Global...including tactical execution by the field Regional Medical Scientific Director (RMSD) teams and is accountable for ensuring field… more
- Sumitomo Pharma (Boston, MA)
- …will be a key member of the Medical Affairs team reporting to the Senior Director , Medical Affairs Strategy. The job is responsible for developing the ... initiatives and advance patient advocacy efforts to ensure that Medical Affairs activities align with patient focused programs. **Job Duties and Responsibilities**… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Position Summary** : Reporting to the Vice President, Global Medical Affairs , the Executive Director , CNS Strategy, Global Medical Affairs is a leadership ... dictate priorities and resources for the function. Leading a team of Medical Affairs professionals, they will ensure Otsuka has the medical insights needed to… more
- Takeda Pharmaceuticals (Boston, MA)
- … strategies in collaboration with their regional counterparts. **_Accountabilities:_** + The Senior Director will be responsible for complex or highly complex ... or oversees direct reports or other staff responsible. The Senior Director will lead all submission types....regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Sumitomo Pharma (Boston, MA)
- …Regulatory Advertising & Promotion** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as ... position of ** Director , ...eg Marketing and their Agencies, Legal, Compliance, and Medical Affairs . + Provide appropriate oversight of promotional material review… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be responsible for ... alignment of the labeling strategy and labeling content. **Interface with Senior Management Cross-Functional Team (GLOC)** + In alignment with TAU/MPD Labeling… more
- Merck (Boston, MA)
- …monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director May Be Responsible For:** + Evaluating pre-clinical ... **Job Description** The Senior Director (Sr. Principal Scientist) has...closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Senior Director , Trade & Channel Launch Excellence **Location:** Morristown, NJ / Cambridge, MA **About the Job** The Senior Director , ... channel partners to shape launch readiness from early commercialization through execution. The Senior Director will serve as a key strategic advisor to executive… more