- 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
- WuXi AppTec (Boston, MA)
- …Technical Marketing Specialist- CMC (San Diego, CA) - Analyze pharmaceutical project and technical requirements for CMC projects for business development; ... and conferences, applying knowledge of chemical engineering, biochemistry, pharmaceutical project management, Chemistry, Manufacturing, and Controls ( CMC )… more
- Parexel (Boston, MA)
- **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
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** **Title: CMC Project Manager** **Location: Cambridge, MA (Hybrid)** **About the role:** As ... a CMC Project Manager, you will provide ...a CMC Project Manager, you will provide project management...management of one or more small molecule products as co- lead with the CMC Lead ;… more
- Takeda Pharmaceuticals (Boston, MA)
- … investigational, registration and/or post-approval strategies for assigned products as GRA CMC Product Lead . + Represents and contributes to Regulatory, ... regulatory requirements and standards. + When in a GRA CMC Product Team lead role, prepares and...across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA… more
- Sumitomo Pharma (Boston, MA)
- …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
- Takeda Pharmaceuticals (Boston, MA)
- …you and empower you to shine? Join us as a Senior Director, Global Program Leader - Oncology, Solid Tumors in our Cambridge office. At Takeda, we are transforming ... to our inspiring, bold mission. **OBJECTIVES:** The Global Program Leader is a seasoned leader fully dedicated,...through the functional sub-teams leaders and their teams all project deliverables achieve defined project scope &… more
- Sumitomo Pharma (Boston, MA)
- …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 (Boston, MA)
- …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 (Boston, MA)
- …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 (Boston, MA)
- **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
- Takeda Pharmaceuticals (Boston, MA)
- …deliver measurable value for patients and the organization. **_Accountabilities:_** + Lead the development and oversight of a comprehensive digital and technology ... as a strategic advisor and technology domain expert for Pharmaceutical Sciences/ CMC scientific and clinical manufacturing informatics and digital solutions +… more
- Takeda Pharmaceuticals (Boston, MA)
- …**_Objective / Purpose:_** The Head of Design & Delivery, PharmSci will lead the global digital product strategy across Takeda's Pharmaceutical Sciences Digital Data ... & Technology (DDT) portfolio driving innovation and operational excellence across the CMC lifecycle. This leadership role is accountable for shaping and delivering… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **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. (Boston, MA)
- …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
- Takeda Pharmaceuticals (Boston, MA)
- …+ Demonstrates strong strategic leadership skills and may function as Global Program Leader on select assets as needed. + Leads program management across a portfolio ... of assets, working closely with the Global Program Leader (GPL), Global Program Managers as well as other...on the GPT. + Demonstrates the ability to bring project teams to consensus, acknowledging both risks and benefits,… more
- CBRE (Boston, MA)
- …Housing loan requests, assessing key areas of risks and conformance with CMC , Fannie Mae and Freddie Mac credit standards and program requirements. Prepares ... techniques/procedures to accomplish assigned tasks and solve problems. + Lead by example and model behaviors that are consistent...you join CBRE, you become part of the global leader in commercial real estate services and investment that… more
