- Larimar Therapeutics (Bala Cynwyd, PA)
- …suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to ... have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good… more
- Larimar Therapeutics (Bala Cynwyd, PA)
- …suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to ... have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good… more
- Larimar Therapeutics (Bala Cynwyd, PA)
- …suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to ... have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good… 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 ... and oversee creation of clinical components of key documents ( regulatory documents, registration dossiers, value dossiers, pharmacoeconomic dossiers) supporting… 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 ... trials, medical review and communication of data, and medical input into regulatory documents, and presentations. This position reports to the Vice President, Multi… more
- Larimar Therapeutics (Bala Cynwyd, PA)
- …suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to ... have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good… more
- Larimar Therapeutics (King Of Prussia, PA)
- …suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (CTI-1601), is a ... consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, manufacturing and CMC. Our company's strategy is to… more
- Larimar Therapeutics (Bala Cynwyd, PA)
- …suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, CTI-1601, is a subcutaneously ... have significant expertise in discovery, nonclinical and clinical development, regulatory affairs and the development of manufacturing processes utilizing good… 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
- 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
- Nelnet (Harrisburg, PA)
- …negotiations for client changes requested for payments contracts. 9. Participate in product reviews to ensure legal and regulatory compliance. 10. Interpret ... Nelnet Business Services (NBS), a division of Nelnet, Inc., provides payment technology , education services, and learning management solutions to education and… more
- Verint Systems, Inc. (Harrisburg, PA)
- …activities on a global basis, as well as being responsible for Verint's regulatory compliance applicable to product related telephony services. The position ... new business models into contract form and negotiation experience for technology related offerings, including technologies for internal business use, resell,… more
- Merck (North Wales, PA)
- …to health authorities globally. Trial Data Management (TDM) is a core business capability that focuses on technology /process simplification and innovation to: ... be more productive and enable innovation. **Responsibilities** As a Product / Business Analyst within the Trial Data Management...problem-solving skills. + Ability to adapt to rapidly changing technology and apply it to business needs.… more
- Merck (West Point, PA)
- …Duties & Responsibilities for the Director Include:** + Sterile drug product development concepts, tools, and technical/ operational/ regulatory requirements ... Qualifications Include:** + Experience in developing liquid, lyophilized, injectable drug product formulations and/or Drug Delivery and Technology initiatives.… more
