- 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
- 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
- Sumitomo Pharma (Boston, MA)
- …supplies on multiple clinical programs. In addition, working closely with CMC, Regulatory Affairs , Quality Assurance, Clinical Operations, and /or SMPA external ... motivated, and experienced individual for the position of **Senior Manager , Clinical Supply Chain** . The Senior Manager...local regulations. + Collaborate closely with Clinical Operations, CMC, Regulatory Affairs , QA, and PDM to ensure… 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
- 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