Alberth Serrano Montero

- Coordinating clinical submissions and regulatory operations under EU CTR/CTD - Managing regulatory documentation in RIM systems and eTMF, ensuring accurate records - Leading start-up and amendment submissions to Authorities and Ethics Committees - Conducting quality reviews of submissions and advising teams on regulatory compliance risks

- Forwarding clinical study documentation to Authorities and Ethics in DACH region - Managing and tracking regulatory invoices, ensuring accuracy and timely approvals - Reviewing informed consent forms for accuracy, cultural adaptation, and compliance - Supporting local teams with meetings, IT troubleshooting, procedure, and document retrieval