Since ****, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. Local Regulatory Representative (LRR), Sr. Assist in aligning local regulatory requirements with Amgen's corporate standards. Review promotional materials to ensure compliance with applicable regulatory requirements and company procedures. Serve as a member of brand teams, providing regulatory input and guidance. Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements. Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures. Ensure regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements.



Act as the point of contact with regulatory agencies in fulfilling local obligations. Participate/contribute to local agency interactions and their preparation. Exchange regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner. Participate in local regulatory process improvements, initiatives and training. Master's degree on Pharmaceutical Industry desirable Fluency in Spanish and English languages. Knowledge of Portuguese would be a plus. Vast opportunities to learn, develop, and move up and across our global organization. Adaptable work arrangements. A biotechnology pioneer since ****, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

📌 Senior Compliance Specialist (España)
🏢 Amgen
📍 España