- Insmed Incorporated (San Diego, CA)
- …Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the ... (fast track, RMAT, etc.)Proactively communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from the VP of … more
- Insmed Incorporated (San Diego, CA)
- …with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs , and external partners.ResponsibilitiesEDC System Design & ... Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director , EDC Programming will lead and oversee EDC programming, and… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Role Overview** The Sr. Director , Clinical Development is an experienced clinical trialist who will be responsible ... into clinical development programs both externally and internally (eg, Medical Affairs , Commercial, CROs, etc.). They will provide clinical / scientific support… more
- Sumitomo Pharma (Tallahassee, FL)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the US,...of the Global Regulatory Affairs (GRA) team based in the US. He/she will… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs , Neuroscience is responsible for developing innovative global ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- CSL Behring (King Of Prussia, PA)
- **The Opportunity** As the Senior Director , Medical Affairs , you will lead the development and execution of Medical Affairs strategies and tactics to support ... leaders in relevant fields + Review and approve medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs , and Commercial +… more
- Orchard Therapeutics (Boston, MA)
- …or PhD in a scientific discipline preferred. . At least 15 years experience in Regulatory Affairs in the Biotech environment, spanning US regulatory science ... Location: Boston, MA Main responsibilities The Executive Director (ED) Regulatory Science will actively...therapy highly desired; experience in the technical development of gene or cell-based therapies and associated regulatory … more
- CSL Behring (King Of Prussia, PA)
- …(PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, 'One GRA ... in more than one key region (EU, US, Japan) * Experience working in Regulatory Affairs with direct agency interaction responsibility with at least 1 health… more
- Lilly (Washington, DC)
- …demonstrate strong independent leadership by proactively engaging with Government Affairs and business colleagues on emerging threats and communicating implications ... including new and emerging technologies and therapeutic areas to Lilly, such as gene therapy, precision medicine, new modalities in cancer care, and new platforms… more
- Sumitomo Pharma (Springfield, IL)
- …oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the US, Canada, and Europe, ... seeking a highly motivated and experienced individual for the position of ** Director , Patient Services** . Primary responsibilities include leading and developing a… more
- Gilead Sciences, Inc. (Frederick, MD)
- …and complex supply chains. + Certification in auditing (eg, ASQ, IRCA) or regulatory affairs . + Familiarity with digital audit tools and data analytics ... providing mentorship, performance evaluations, and long-term career development. The Director ensures compliance with global regulatory requirements, marketing… more
- Fujifilm (College Station, TX)
- …Collaboration** : Work closely with the Quality Assurance, Manufacturing, and Regulatory Affairs teams to support product development and ensure ... **Position Overview** As the Associate Director of Microbiology, you will play a pivotal...a contamination-free environment, support our product pipeline, and ensure regulatory compliance. **Company Overview** The work we do at… more
- CSL Behring (King Of Prussia, PA)
- …successful regulatory outcomes.** **Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, ... days a week. You will report to the Executive Director Head Regulatory . **Position Description** **Summary** **...one key region (EU, US, Japan)** **Experience working in Regulatory Affairs with agency interaction responsibility with… more
- University of Colorado (Aurora, CO)
- …trends and opportunities for improvement (OFI) through audits and occurrence reports to the Director of Regulatory Affairs and/or Quality Manager, which are ... fit for use. + Performs review of cell and gene therapy product files and sponsor protocols, ensuring accurate...- four (4) years of related quality assurance and regulatory affairs experience in a clinical laboratory.… more
- Pfizer (Helena, MT)
- …important support networks. The role reports directly to the Rare Disease US Patient Affairs Senior Director . **Why Patients Need You:** + For many patients with ... Particularly in hemophilia with many new emerging therapies (eg, Gene Therapy, TFPI class), patients need to understand the...for patients. + Collaborate with Pfizer's State and Government Affairs Team to support PAGs with state and local… more
- University of Pennsylvania (Philadelphia, PA)
- …processing and shipping of biofluids; Data entry; Query management; Maintaining regulatory documents and binders for clinical trials; Assisting with invoicing for ... coordinators and research assistants. Works closely with CROs, industry sponsors, regulatory agencies, and other stakeholders; Participates in study team meetings,… more
- Pfizer (MS)
- …compassionate, strategic, and organized Patient Navigator (PN) to join our US Patient Affairs Team. The Patient Navigator will serve as a guide for patients through ... The PN role reports directly to the Rare Disease Patient Engagement Senior Director . The objectives of the Patient Navigator (PN) role are: + **Patient Education… more
