- 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
- 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
