manufacturing process and analytical methods Author and/or review CMC regulatory submissions Support QA with quality systems... closely with Technical Operations, R&D, Quality Control, Regulatory Affairs, and Supply Chain teams to support technology...
, CMC, regulatory affairs, and QA. Working knowledge of cGMP’s (CFR/ICH) and GCP and applicable international regulations... to support communities through philanthropy and volunteerism. Position Summary: The Associate Director, Clinical Supply...
organizations such as Regulatory Affairs, Process Development, Analytical Development, Manufacturing Sciences & Technology... as quality reviewer of CMC sections of Regulatory submissions and response to global agencies queries for various product...
(s). Partner with regulatory affairs to assess new and emerging regulations and apply in a fit for purpose manner to Bicycle... with Regulatory Affairs and Quality to ensure regulatory submissions compliant to GxP and global regulations. Coordinate the...
with other functional leaders in CMC, Regulatory Affairs, Clinical Operation and Quality Assurance in support of the study project teams... Operations, Clinical Operations, Regulatory Affairs, Quality Assurance, and external vendors to execute the strategies for the...
authoring of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC...: The Medical Director Oncology Clinical Development will report to the Executive Medical Director, Clinical Development...
department as they relate to support of CMC, Technical Operations, Regulatory Affairs, Medical Affairs, Clinical Operations... Director, Quality Assurance, is responsible for overseeing and managing the day-to-day activities of the Quality Assurance...
with the CMC, supply chain, clinical operations, regulatory, quality and management teams. The position reports to the Sr... as independently as possible. Key interactions with the CMC, supply chain, clinical operations, regulatory, quality and management...
, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and external..., Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the timely completion...
, CMC and Regulatory Affairs teams to deliver and drive the timely completion of all clinical activities related to emerging... department Work with the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory...
, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and external stakeholders..., Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the timely completion...
, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and external..., Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the timely completion...
, CMC and Regulatory Affairs teams to deliver and drive the timely completion of all clinical activities related to emerging... department. Work with the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory...
, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams... regulatory requirements Work with, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC...
questions and annual reports. Serving as the liaison between CMC/Regulatory Affairs and Subject Matter Experts on issues..., process validation, process controls, compliance, continuous process optimization, CMC regulatory support, manufacturing data...
, summaries for regulatory submissions). The Director will provide input to the clinical development plan and will provide..., pharmacovigilance, CMC, and pre-clinical development in this regard. The Director will be a key contributor to and responsible for the...
, Supply Chain, Manufacturing, CMC Regulatory Affairs, Finance and Technical Development for successful commercialization... molecules. Position Summary The Executive Director Analytical Sciences & Technology will lead the analytical development...
Director will collaborate with teams, including R&D, Quality, Manufacturing, and Regulatory Affairs, to the... regulatory CMC packages for IND filings and approval applications (BLA/MAA/NDA). Address process development inquiries...
, Regulatory Affairs, Clinical Operations, Translational, CMC, and early development groups. Your expert scientific input..., regulatory, safety, CMC, commercial operations. Experience proactively integrates multiple perspectives into the clinical...
continuity. Cross-Functional Collaboration & Compliance: Work closely with CMC Manufacturing, Quality Assurance, Regulatory.... This is life-changing work, and we are all in, are you? Akebia Therapeutics is seeking a dynamic and experienced Director, Global...