Clinical Trials Regulatory Submission Manager
About this role
About the Role This role defines and executes the overall submission strategy and manages all regulatory activities for clinical trial projects and programs. In Brazil, the position is directly accountable for clinical trial application preparation and submission to ANVISA, while in other specified countries it oversees outsourced FSP activities and serves as the primary communication point under the Amgen FSP hub model. What You'll Do
- Lead the end-to-end management of Clinical Trial Applications (CTAs) and regulatory submissions in Brazil for new and ongoing clinical development projects and programs, ensuring full compliance with local regulatory requirements.
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