Óscar Martínez Antón

Focuses on specific duties and technical platforms.

• Lifecycle Management: Led the submission and maintenance of Marketing Authorizations (MA), including variations, local representative duties, renewals, suspension and revocations, ensuring 100% alignment with Health Authority requirements.
• Technical Operations: Expert in eCTD creation and dossier management, with a specific focus on Module 1 and Module 3 (CMC) quality and integrity.
• Compliance & Safety: Managed critical safety dossiers, including Nitrosamine risk assessments, implementation of serialization services through EMVO and NMVOs and serialization alerts management (EAMS).
• Regulatory Digital Strategy: Advanced user of Spanish regulatory platforms, including RAEFAR, the Fraccionamiento platform, and Medicamentos en Situaciones Especiales (MSE).
• Cross-Functional Support: Provided strategic regulatory guidance to marketing and production teams, overseeing the approval of promotional materials and the update of artworks/labeling.

Responsible for end-to-end prescription fulfillment and clinical validation, ensuring the highest standards of medication safety and accuracy. I provide expert patient counseling on administration, side-effect management, and storage while collaborating closely with multidisciplinary healthcare teams to resolve clinical discrepancies and optimize patient outcomes.

• Main contact with sites, performing independent monitoring visits, evaluates and ensures patient safety, data quality, and adherence to the protocol and agreed SOPs. Complies with overall study timelines to maintain recruitment progress, data cleaning and appropriate IMP management. Creating, distributing and maintaining all relevant study documentation.

Expatriate Project Lead & Clinical Pharmacist | St. Joseph’s Hospital, Uganda

Served as the sole on-site representative for the Foundation in Northern Uganda, spearheading the modernization of pharmaceutical services at St. Joseph’s Hospital Kitgum. I successfully established and coordinated the Unidose Dispensing Department and designed a specialized Compounding Laboratory from the ground up. My mission focused on sustainability through the technical training of local staff, ensuring long-term operational excellence in a resource-limited setting.

Developed strong multitasking, teamwork, and customer service skills in a high-pressure, fast-paced environment.