- 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 (Topeka, KS)
- …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
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. Eli Lilly and Company seeks a Regulatory Affairs Director (R7-R8) to support the execution of regulatory ... followed by 5 years of progressively responsible experience with supporting regulatory affairs for pharmaceutical development projects and marketed products.… more
- Sumitomo Pharma (Cheyenne, WY)
- …Director , Medical Strategy (Prostate Cancer) will be a key member of the Medical Affairs team reporting to the Senior Director , Medical Affairs Strategy. ... health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the US,...and advance patient advocacy efforts to ensure that Medical Affairs activities align with patient focused programs. **Job Duties… more
- Actalent (Boston, MA)
- Job Title: Director Regulatory CMC Job Description We are seeking a creative and agile regulatory professional eager to join a collaborative team as a ... Director /Sr. Director of Regulatory CMC...+ Minimum of 8+ years of experience in CMC Regulatory Affairs for biologics, including IND activity,… more
- Sumitomo Pharma (Madison, WI)
- …Regulatory Advertising & Promotion** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as ... health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the US, Canada,...the position of ** Director , … 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
- 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 (Indianapolis, IN)
- …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
- Sumitomo Pharma (Harrisburg, PA)
- …relevant cross-functional stakeholders, including in Commercial, Clinical Development, Medical Affairs , Regulatory , Sales leadership and Finance/IR functions. ... oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the US, Canada, and Europe,… more
- Sanofi Group (Cambridge, MA)
- …Research Director , Safety Officer and Pharmacovigilance, Translational Medicine, Regulatory Affairs , Biostatistics, Clinical Study Units, Medical Affairs ... **Job Title:** Development Scientific Director (DSD) **Location:** Cambridge, MA, **About the Job**...to the protocol development, study feasibility and risk assessment, regulatory submissions, protocol training, scientific review of data, and… 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
- 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
- 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
