- Cardinal Health (Boston, MA)
- …plans for product development programs and regulatory submissions. **_Job Summary_** The Manager , Regulatory Affairs directs regulatory affairs ... **_What Regulatory Affairs contributes to Cardinal Health_**... authorities and provides insights to senior leadership regarding regulatory developments. The Manager leads a team… more
- Takeda Pharmaceuticals (Boston, MA)
- …for the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Manager , Global Regulatory Affairs , Marketed Products **POSITION ... : Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs , Marketed...Regulatory submissions to US FDA, EU, and other international health authorities: Manage the authoring, review cycles, finalization,… more
- Takeda Pharmaceuticals (Boston, MA)
- …drug and device. + Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device Sub team to ensure that ... patients with immunologic, hematologic, and other complex diseases. The Global Regulatory Device Labeling Strategy Lead (Senior Manager ) Plasma-Derived Therapies… more
- Grifols Shared Services North America, Inc (Medford, MA)
- …8 or more years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or ... Hiring Ordinance.** Learn more about Grifols (https://www.grifols.com/en/what-we-do) **Req ID:** 527460 **Type:** Regular Full-Time **Job Category:** Regulatory Affairs… more
- Fresenius Medical Center (Waltham, MA)
- …+ Experience in project management respectively change control process + Experience in regulatory affairs or in a quality environment, ideally in a ... The internal Job Title is called **Global Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products).** **Main Responsibilities:** + Support as … more
- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required ... AND RESPONSIBILITIES:** + A seasoned, experienced professional with a full understanding of Regulatory Affairs ; resolves a wide range of issues in creative ways.… more
- ICON Clinical Research (Boston, MA)
- …and preventive system to ensure continued compliance to domestic and international regulatory regulations and documentation/records requirements + Provide ... Notified Bodies) to ensure continued compliance to domestic and international regulatory regulations + Support generation of...device labeling + Work closely with Design Controls and Regulatory Affairs teams to ensure alignment of… more
- State of Massachusetts (Boston, MA)
- …of Banks is currently accepting applications for the position of IT/Cybersecurity/FinTech Manager . This role will be responsible for overseeing a team of examiners ... learn more about the Division of Banks, click here. *As an IT/Cybersecurity/FinTech Manager , you can expect to: * * Manage the supervisory activities associated with… more
- Fujifilm (Boston, MA)
- …+ Proven track record working with Marketing, Business Development, Engineering/QA, and Regulatory Affairs . + Competitive knowledge of Medical IT and Imaging ... for the Fujifilm Healthcare Americas Corporation IT portfolio. The Global Product Manager (GPM) is responsible for developing product plans, acting as a Product… more
- Cardinal Health (Boston, MA)
- …partners across enterprise, including R&D, Regulatory , Clinical Affairs , Sourcing, Manufacturing, Strategy Functions, Downstream Marketing, International ... pediatric, and neonatal enteral feeding products. The Global Portfolio Manager is an upstream marketing leader for the global...NICU. Support developing business needs by: + Global product manager for NTrainer platform + Serve as product … more
- Takeda Pharmaceuticals (Lexington, MA)
- …program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug development ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC, Marketing). + Minimum of 5… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …facilitating cross-functional engagement with stakeholders across Clinical Development, Global Regulatory Affairs , Global Manufacturing Sciences, Global Product ... & Launch Strategy, Global Communications, and Global Medical Affairs , as well as regional launch leads in the...on critical path tactics. Collaborate with the Global Program Manager (GPM) and regional launch leads to align timelines… more