Regulatory Submissions Jobs in Fishers, IN

See Yourself at TelixWe are seeking a dynamic and experienced Sr. Global Clinical Lead in Prostate Cancer Imaging as part of our Clinical Strategy and Innovation team. The successful candidate will be responsible for designing and executing clinical trials for novel radiopharmaceutica More...

The Scientific Director International Medical Affairs - Gastroenterology provides medical and scientific strategic and operational input into core medical affairs activities including but not limited to: health-care professional and provider interactions; generation of clinical and sc More...

See Yourself at TelixTo support the Groups strategic objectives the Manager GRA Global will oversee Regulatory Affairs for commercial registration activities of PSMA portfolio globally. This role involves conducting regulatory tasks related to new product development securing registra More...

See Yourself at TelixThe Senior Clinical Project Manager (SCPM) reports to the Senior/Director of Clinical Operations who bears primary responsibility for the execution of Telixs clinical trials. The SCPM is responsible for the successful execution of national and global clinical tria More...

POSITION SUMMARY:The InHouse Clinical Data Manager will be responsible for a range of data management tasks contributing to the success of clinical trials and regulatory submissions in accordance with Good Clinical Practices and applicable regulations including the Code of Federal Reg More...

See Yourself at TelixThe Vice President Network Development is responsible for leading the national strategy and execution of contract development and manufacturing (CDMO) activities. This role drives the development of internal drug manufacturing capabilities including process optimi More...

See Yourself at TelixAs the Principal Scientist Biomarker and Assay Development you will lead and oversee the development and validation of translational assays to evaluate biomarkers for safety and efficacy in support of both large and small molecules across the Diagnostic and Therap More...

General SummaryUnder limited supervision develops analyzes reports and interprets complex financial information to assist management in evaluating and executing the organizations business plans in compliance with the Health Services Cost Review Commission (HSCRC) and Center for Medica More...

See Yourself at TelixTo support the Groups strategic objectives the Manager GRA Global will oversee Regulatory Affairs for commercial registration activities of PSMA portfolio globally. This role involves conducting regulatory tasks related to new product development securing registra More...

About This Role:As a Medical Director Clinical Development Immunology you will be an integral member of the Immunology Therapeutic Area within the Clinical Development Organization. In this dynamic role you will play a critical part in shaping and advancing clinical programs particula More...

Responsibilities: Develop test and validate SAS programs to generate analysis datasets (ADaM) TLFs and adhoc reports. Ensure datasets and outputs adhere to CDISC standards and regulatory guidelines (e.g. FDA EMA). Collaborate with Biostatisticians Data Management and Clinical Teams More...

See Yourself at TelixThe Manager GRA CMC is responsible for managing CMC specific regulatory activities for the development and commercialization of pharmaceutical products. This role requires excellent understanding of technical (Quality/CMC) regulatory requirements guidance the abi More...

See Yourself at TelixTelix is seeking applicants for a Radiochemist position to support the development of its Precision Medicine commercial and clinical stage radiopharmaceutical assets. The successful candidate will be responsible for managing the radiochemistry development required More...