- Genmab (Yardley, PA)
- …as marketing applications (eg, BLAs/MAAs). Evaluate competitive landscape and various regulatory mechanisms that allow optimization of product development (eg, ... people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we...passionate leader to be a part of our Global Regulatory Affairs (GRA) organization. In this role, you will… more
- Genmab (Yardley, PA)
- …accuracy, completeness, and compliance with regulations and guidelines. Evaluate various regulatory mechanisms to optimize product development (eg, orphan drug ... people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we...passionate leader to be a part of our Global Regulatory Affairs (GRA) organization. In this role, the … more
- Genmab (Yardley, PA)
- …IT & Digital, you will have a critical role in overseeing the product strategy, development/implementation and management of technology products in different ... delivery. In this role, you will collaborate closely with Business to help define product vision and...a technical solution and articulate it back to the business stakeholders. Solid understanding of regulatory guidelines… more
- Genmab (Morrisville, PA)
- …and healthcare providers. The focus of this role will include stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US Market ... and Compliance team, in particular security architects and Genmab Security Operations Team Business leaders (eg, VP Medical Affairs, VP Regulatory Affairs, GM… more
- Genmab (Yardley, PA)
- …serious diseases. From our people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we believe that being proudly ... be responsible for developing and executing robust epidemiology plans for Genmab product portfolio and pipeline in alignment with clinical development, global drug… more
- Genmab (Morrisville, PA)
- …serious diseases. From our people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we believe that being proudly ... understanding of disease biology and treatment targets to work using innovative antibody technology platforms. From the way we design and conduct our clinical trials… more
- Genmab (Morrisville, PA)
- …serious diseases. From our people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we believe that being proudly ... and oversee creation of clinical components of key documents ( regulatory documents, registration dossiers, value dossiers, pharmacoeconomic dossiers) supporting… more
- Genmab (Morrisville, PA)
- …serious diseases. From our people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we believe that being proudly ... trials, medical review and communication of data, and medical input into regulatory documents, and presentations. This position reports to the Vice President, Multi… more
- Genmab (Yardley, PA)
- …serious diseases. From our people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we believe that being proudly ... research, epidemiology and real-world evidence plans for a leading pipeline product (oncology) in alignment with brand strategies, medical affairs strategies,… more
- Genmab (Yardley, PA)
- …serious diseases. From our people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we believe that being proudly ... will be a key member of the USMA leadership team, contributing to product launches & development efforts, responsible for shaping team culture & employee… more
- Genmab (Morrisville, PA)
- …practices in data science. Report scientific results in patents, publications, regulatory documents, and product -development reports. Requirements MS or Ph.D. ... people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we...& AI teams. Work on projects in partnership with technology companies and academic institutes to bring new AI… more
- Organon & Co. (Plymouth Meeting, PA)
- …- Regulatory Technology Products will report directly to the Director of Regulatory Business Technology and will be a key member of the Organon ... Research and Development (R&D) Business Technology team. This position is responsible...technology products or platforms for the Organon R&D Regulatory area. The position is accountable for both technical… more
- PNC (Pittsburgh, PA)
- …Objects, Problem Solving, Process Management, Project Management, Requirements Analysis, Software Product Business Knowledge **Work Experience** Roles at this ... have an opportunity to contribute to the company's success. As a Sr. Business Analyst within PNC's Finance- Control/ Regulatory Reporting organization, you can… more
- PNC (Philadelphia, PA)
- …Capture, Problem Solving, Process Management, Project Management, Requirements Analysis, Software Product Business Knowledge **Work Experience** Roles at this ... have an opportunity to contribute to the company's success. As a Business Analysis Advisor within PNC's Finance- Control/ Regulatory Reporting organization, you… more
- Sanofi Group (Swiftwater, PA)
- …a scientific or engineering discipline with at least 6 years of relevant combination product regulatory experience or a combination of a Master's degree and ... drug development and registration. + Proven experience in drug/device combination product regulatory approvals. + Demonstrate strategic thinking, initiative,… more
- Globus Medical, Inc (Audubon, PA)
- …and documents all related activates to remain in compliance + Demonstrates global regulatory expertise in product submissions and evaluates changes with local ... procedures and regulatory decisions for new or existing products + Reviews regulatory requirements from other departments for new product designs or changes… more
- Teleflex (Wyomissing, PA)
- …and submissions for complex projects and review issues related to regulatory documents, investigations, product development planning and regulatory ... Sr. Regulatory Affairs Specialist **Date:** Jun 26, 2024 **Location:**...diverse organization within the company which is responsible for product fulfilment to all our customers from end to… more
- Philips (Reedsville, PA)
- …deliverables. **Your role:** + Serve as RA Representative on project teams, develops regulatory submission strategies for new product launch, and provide ... development and review process to ensure timely submission approval. + Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and… more
- Takeda Pharmaceuticals (Harrisburg, PA)
- …global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology and process is required. + At ... operational support for assigned programs. + Partnering with the program Global Regulatory Lead (GRL), co-lead and facilitate product -specific Global … more
- Globus Medical, Inc (Audubon, PA)
- …knowledge of IDE and PMA submissions a plus + Experience assessing regulatory impact of product /process changes + Experience reviewing labeling, promotional ... can resume their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions,… more
