You will be responsible for developing and executing regulatory strategies for Expanded Access Programs (EAP) for biologicals, cell therapy, and synthetic drugs. You will also represent Regulatory Affairs and Pharmacovigilance as a Subject Matter Expert in various situations and compile and submit regulatory dossiers for cohort and named patient expanded access programs on behalf of clients. Moreover, you will consult clients and the Commercial team on strategy for setting up and executing an expanded access program. You'll manage all Regulatory and Pharmacovigilance aspects of EAP's and maintain up-to-date knowledge of related laws, regulations, and guidelines. You will also assist in the preparation, writing, and review of regulatory content and support, control, and manage the Pharmacovigilance service provider. As the department head, you will be responsible for SOPs, QIs, and CAPAs allocated to the department. Finally, you will mentor team members, nurture personal development, and ensure a high performing environment.