- Otsuka America Pharmaceutical Inc. (Boston, MA)
- We are seeking a Senior Director , Federal Government Affairs to lead our US federal government engagement in Washington, DC. This position reports to the Vice ... the strategic leader, and a member of the Government Affairs Leadership Team, the Senior Director of...Affairs , setting a vision for the operation and managing resources to achieve policy, legislative, regulatory, and reputational… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the Job** Are you ... Your skills could be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs - Global Labeling Strategy is responsible for… more
- Edwards Lifesciences (Boston, MA)
- Patients are at the heart of everything we do. As the Senior Director , THV Medical Affairs , you will drive strategy development, evidence generation initiatives, ... economics and outcomes research teams ensuring seamless integration of medical affairs initiatives into broader organizational efforts. + Building and maintaining… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …and multicultural environment and leverages their extensive experience to represent regulatory affairs in discussions with external and internal stakeholders. A ... you will build and lead a cell medicine regulatory affairs team and provide regulatory leadership and oversight to...typical day as an Executive Director might look like: + Responsible for the strategic… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready to shape ... departmental activities, and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance and advice during issues… more
- Fresenius Medical Center (Waltham, MA)
- …This position plays a critical role in influencing regulatory decisions, managing complex global submissions, and ensuring successful product development, approval, ... portfolio. The Global Strategy Leader will work closely with internal and external stakeholders to align regulatory strategies with business objectives and drive the… more
- United Therapeutics (Boston, MA)
- …kidneys ( **mirokidney(R)** ), livers ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** ... a regulatory strategist who will advise on regulatory pathways, managing documentation and timelines, and supporting the preparation and...with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+… more
- Takeda Pharmaceuticals (Boston, MA)
- …success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally governance technical ... review committees, key global health authority meetings and external partners. + Participates with influence in or leads departmental and cross-functional… more
- Takeda Pharmaceuticals (Lexington, MA)
- …communicates issues with clear recommendations to key internal and external colleagues, including Alliance Partners. + Successfully communicates and negotiates ... and influential working relationships when interacting with internal and/or external colleagues. + Providing strategic input into change control evaluation… more
- Takeda Pharmaceuticals (Boston, MA)
- …difference to millions of patients around the world. The medical/scientific director will provide scientific & team leadership, guidance across global medical ... affairs activities including evidence data generation, data analysis and...& reimbursement (PMA) data generation, analysis and publications. Medical/Scientific director will work in a multifunctional, matrix organization with… more