Senior Associate/Manager, Regulatory Sciences

We are on the hunt for bold, innovative thinkers who are ready to help push the boundaries of science and make a tangible difference in the world. The role drives strategic input into clinical study design, ensures excellence in data management, and supports successful regulatory submissions. You will work independently on multiple projects, leading trials in rare diseases and overseeing timelines and quality control. Provide statistical expertise in clinical planning, study design, and protocol development. Develop statistical analysis methodologies and plans Perform blinded in-trial data quality reviews and pre-database lock data quality control. Oversee the preparation and integration of clinical regulatory submission packages. Collaborate with cross-functional teams including clinicians, clinical operations, and regulatory affairs. Lead and drive submissions, ensuring adherence to regulatory requirements. Expertise in SAS and R programming for data management and statistical analysis Proficiency in MS Word, Excel, and PowerPoint. Sound knowledge of clinical and statistical regulatory requirements (e.g., Ability to manage multiple clinical trials and oversee quality control processes. By submitting this application, you confirm that you\’ve read and understood our privacy policy, which informs you how we process and safeguard your data –