- Sumitomo Pharma (Boston, MA)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and...is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will… more
- Sumitomo Pharma (Boston, MA)
- …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
- 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
- Actalent (Cambridge, MA)
- …and/or other service providers. + Contribute to biostatistics, medical writing, safety, regulatory affairs , and quality assurance activities. + Interact closely ... Associate Director , Clinical Operations Job Description Manage clinical trial...role or someone coming from an AD position. + Gene therapy experience would be a nice to have.… more
- CSL Behring (Waltham, MA)
- …(PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, 'One GRA ... 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
- Takeda Pharmaceuticals (Lexington, MA)
- …analysis and sustainable CAPA. + Collaborate cross-functionally with Pharmaceutical Sciences, Regulatory Affairs , Manufacturing, and other Quality functions. + ... Partner with cross-functional teams to support analytical lifecycle management and regulatory submission readiness. + Lead key quality initiatives and investigations… more