- Fusion Pharmaceuticals (Providence, RI)
- …for Fusion's growing pipeline of RCs. Fusion Pharmaceutical is opening a role for a CMC Project Leader . Reporting to the Vice President of Manufacturing, ... this individual will be responsible for leading CMC efforts for our lead asset, FPI-2265...The successful candidate will bring a strong background in CMC and Project leadership. This position is… more
- Parexel (Providence, RI)
- **Join Parexel as a Post-Approval Regulatory Strategy Lead !** Are you a strategic thinker with a passion for navigating the complex world of global regulatory ... love to connect. We are seeking a dynamic and experienced Post-Approval Regulatory Strategy Lead to join our Regulatory Affairs team. In this pivotal role, you will… more
- Sumitomo Pharma (Providence, RI)
- …in line with the global registration strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of ... team based in the US. He/She will primarily function as a regional regulatory leader (RRL) and/or Global Regulatory Leader (GRL) for assigned products. This… more
- Sumitomo Pharma (Providence, RI)
- …team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This ... position is expected to lead the development and implementation of regulatory strategy from...Global Regulatory Team (GRT), leads regulatory activities for assigned project (s) in line with the global registration strategy of… more
- Merck (Providence, RI)
- …to the Sr. Director of Device Product Assessment & Innovation (DPAI), the Director, Lead of Strategy for Device Product Assessment & Innovation will define and build ... decision-making strategy for all elements of early development. They will lead various early development and innovation initiatives to support continuous improvement… more
- Bausch + Lomb (Providence, RI)
- …influencing key stakeholders, and optimizing business outcomes. **Responsibilities:** + Formulate, lead , and drive integrated regulatory strategies across CMC ... + Participate in assigned due diligence activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA… more
- Parexel (Providence, RI)
- **Join Parexel as a Post-Approval Regulatory Strategy Lead !** Are you a strategic thinker with a passion for navigating the complex world of global regulatory ... love to connect. We are seeking a dynamic and experienced Post-Approval Regulatory Strategy Lead to join our Regulatory Affairs team. In this pivotal role, you will… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- **Associate Director, Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and drug ... product at CDMOs + Design and lead method validation and implementation activities for drug substance...and reporting, providing actionable insights and recommendations to optimize project outputs for the project teams and… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …activities for all assigned projects in alignment with the Global Regulatory Lead . Translates complex pertinent global requirements and provides an assessment of the ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works… more
