- Sumitomo Pharma (Raleigh, NC)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... of the Global Regulatory Affairs (GRA) team based in the US. He/she will...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- Merck (Raleigh, NC)
- …Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development ... control activities and documentation reviews + Provide evaluations of regulatory state of affairs of any devices and combination products, for due diligence… more
- Danaher Corporation (Raleigh, NC)
- … Affairs department and report to the Vice President of Global Quality and Regulatory Affairs . The Director of Global Regulatory Affairs ... that safeguard and improve human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and will be fully remote. At Aldevron, we… more
- Takeda Pharmaceuticals (Raleigh, NC)
- …of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices and… more
- ThermoFisher Scientific (Mebane, NC)
- …will also be responsible for talent development within the team. Reporting to the Senior Director of Regulatory Affairs , the incumbent will serve as a member ... services through our industry-leading brands. Position Summary Lead the global Regulatory Affairs (RA) team and provide organizational guidance and… more
- Wells Fargo (Charlotte, NC)
- …Fargo is seeking an Assistant General Counsel, Executive Director on our Public, Regulatory and Corporate Affairs Legal team to provide legal support on a ... of issues. This role will be in the Public Affairs section, which supports Public Affairs , including...Familiarity with enterprise risk management frameworks and functions and regulatory expectations for risk management at large banks and… more
- Chiesi (Cary, NC)
- Scientific Director US Medical Affairs , Pulmonary Hypertension Date: Jan 6, 2025 Department: Medical Affairs Job Type: Direct Employee Team: Mktg, Market ... is to lead the development, execution, and implementation of the global Medical Affairs strategy for Seralutinib within the US market in partnership with Gossamer… more
- Sumitomo Pharma (Raleigh, NC)
- …website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. **Job Overview** The Director , Medical Affairs Strategy (Hematology/Oncology) will be a key ... member of the Medical Affairs team reporting to the Executive Director ,...confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and procedures, by ensuring… more
- Sumitomo Pharma (Raleigh, NC)
- …Director , Medical Strategy (Rare Disease) will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... company programs and external facing HCP and Payer interactions. The Sr. Director of Medical Affairs develops and maintains professional relationships with… more
- Sumitomo Pharma (Raleigh, NC)
- …, Medical Strategy (Prostate Cancer)** will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... initiatives and advance patient advocacy efforts to ensure that Medical Affairs activities align with patient focused programs. **Job Duties and Responsibilities**… more
- Merck (Raleigh, NC)
- **Job Description** **Role Summary** + The Health Systems Medical Affairs Director (HS MAD) is a therapeutic and disease expert who develops ongoing professional ... in a balanced and credible manner consistent with the regulatory environment and company's ethical standards. This role also...resource for the HS MAD Team Lead, HS Executive Director Medical Affairs , and other members of… more
- Cypress Creek Renewables (Raleigh, NC)
- Associate Director / Director of Government Affairs - Southeast at Cypress Creek Renewables (View all jobs) (https://ccrenew.com/careers/) Raleigh, Durham, NC ... a talented and highly motivated individual to work as part of our Government Affairs team covering the Carolinas, with potential to expand to other Southeast states… more
- Fujifilm (Raleigh, NC)
- **Overview** We are hiring a Director of State Government Affairs to be based in the Raleigh, North Carolina area. The Director , State Government Affairs ... of tactics in support of members' state legislative and regulatory activity. + Advise and inform state level officials...tracking of the relevant aspects of the State Government Affairs & Public Policy budget. + Work collaboratively with… more
- Takeda Pharmaceuticals (Raleigh, NC)
- … Project Management and Strategic Planning - Neuroscience TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global ... changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project Management… more
- Takeda Pharmaceuticals (Raleigh, NC)
- …innovative opportunities to improve processes and infrastructure in line with global regulatory expectations and Global Regulatory Affairs (GRA) technology ... goals. + Demonstrates leadership and a deep understanding of global regulatory affairs (GRA) information/data regulations and guidelines, proactively addressing… more
- Sumitomo Pharma (Raleigh, NC)
- …. **Job Overview** The **Executive Director Head of Medical Strategy** will ... be a key member of the Medical Affairs Leadership team reporting to the Vice President,...confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and procedures, by ensuring… more
- Teleflex (Morrisville, NC)
- …by clinicians and their patients. **Principal Responsibilities** Quality Assurance and Regulatory Affairs * Provide subject matter expertise for discussions ... Director . As part of the Clinical and Medical Affairs (CMA) function and in partnership with QARA, this...* Experience in literature identification and analysis required * Regulatory experience preferred * Clinical and Medical Affairs… more
- Reynolds American (Winston Salem, NC)
- …- Cross-functional: Submissions, Product Development, Marketing, Legal & External Affairs , Procurement, Regulatory Compliance **External** - several CROs ... Sr Director Population Health/Consumer Behavior Winston-Salem, North Carolina **Reynolds...and human factors and actual use testing, to support regulatory requirements. This position is a senior level position… more
- Takeda Pharmaceuticals (Raleigh, NC)
- …Senior Management Cross-Functional Team (GLOC)** + In alignment with Head, Global Regulatory Affairs Marketed Products and Labeling, coordinates the process to ... plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. The Director , Global Labeling Strategy Lead is a key role in the PDT… more
- Organon & Co. (Raleigh, NC)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... position can be 100% remote in the US** The Director , Translational Medicine and Early Development (TMED) Lead will...are sound, based on the most up-to-date literature and regulatory guidances and support the approved early development plans.… more