JOB SUMMARY. The GMP Quality Assurance contractor will assist with quality oversight activities for GMP activities including batch record review for release and stability testing of drug substance and drug product. They will assist in the review of compliance documents with established standards and regulations. Collaborate with cross functional CMC team members and support Gossamer cGMP activities. ESSENTIAL DUTIES AND RESPONSIBILITIES. Review/A...
Summary. The Exec Dir / VP, Regulatory Affairs will be responsible for leading the development and implementation of a consolidated regulatory strategy to secure and maintain market access for the assigned product in a specific indication. The ED/VP is also responsible for establishing and maintaining effective relationships with regulatory agencies, especially the FDA. This role will participate as a core project team member and will manage pers...
Summary. The Global Clinical Scientist, Clinical Development will have a key role in supporting the clinical development of seralutinib for the treatment of pulmonary arterial hypertension (PAH). This includes contributing and having day-to-day responsibilities related to the conduct of the Phase 3 PROSERA study in PAH. This role will work in conjunction with the Clinical Development Lead, Study Teams, CRO, Clinical Operations, and Medical Aff...
