- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Clinical Regulatory Location: Brisbane, California About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical -stage ... medical treatment for patients suffering from immunological diseases. Position Summary: The Senior Manager , Clinical Regulatory will report to the… more
- Sumitomo Pharma (Frankfort, KY)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Senior Manager , Regulatory Affairs** . The Senior ... Manager is part of the Global Regulatory Affairs (GRA) team based in the US and...+ Leads the preparation, coordination and monitoring of worldwide regulatory submissions related to clinical trials and… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Sr. Manager , CTA Regulatory Strategy is responsible for providing critical support in developing global regulatory strategy, planning, and execution of ... global investigational submissions and manages lifecycle regulatory activities for assigned Clinical Trial Application projects in alignment with the Global … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As an Senior Manager , Global Regulatory Affairs, Precision Medicine, you ... as applicable. You will provide fit-for-purpose operational and technical diagnostics (Dx) regulatory assistance through all stages of drug clinical programs,… more
- Abbott (Plano, TX)
- …Clara, CA currently have an opportunity for a ** Clinical Risk Evaluation (CRE) Senior Scientist/Program Manager ** . The Clinical Risk Evaluation (CRE) ... product performance, medical affairs, Clinical R&D, Quality Engineering, regulatory affairs, product labeling, senior management, and external CROs… more
- Takeda Pharmaceuticals (Boston, MA)
- …and other complex diseases. The Global Regulatory Device Labeling Strategy Lead ( Senior Manager ) Plasma-Derived Therapies Business Unit (PDT BU) is a key ... the Head of Global Labeling and is: + Responsible, for providing regulatory expertise, strategic insight, and guidance to internal stakeholders, including … more
- Pfizer (Bothell, WA)
- **ROLE SUMMARY:** The Senior Manager , Oncology Early Stage Clinical Scientist will work collaboratively with the Global Development Lead (and members of the ... encourages strong partnerships and mutual trust. + Supports the GDL and senior clinical scientist, in developing effective collaborations with project leaders… more
- Amgen (Washington, DC)
- …Join us and transform the lives of patients while transforming your career. **Global Regulatory Policy and Intelligence Manager ** **What you will do** The United ... States Regulatory Lead (USRL), Sr. Manager is assigned to one or more Amgen products,...clinical studies in accordance with national legal and regulatory requirements (where appropriate). + Monitors changes in the… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** The Senior Regulatory Affairs Manager will provide strategic leadership to support new product development (NPD) programs for our ... global business unit portfolio. This role involves providing regulatory guidance and support throughout all stages of NPD, including supporting submissions for… more
- Edwards Lifesciences (Naperville, IL)
- …longer and healthier lives. Join us and be part of our inspiring journey. The Senior Manager , Clinical Product Quality will plan and lead initiatives around ... and documentation of product complaints, including reporting of events to regulatory Agencies. Provide Medical/ Clinical Guidance to Complaint Staff and… more