Simone Saenz

Simone Saenz currently serves as the Senior Technical Regulatory Affairs Manager (CMC) at Santhera Pharmaceuticals, where she leverages over 13 years of extensive experience in drug regulatory affairs within the biotechnological and chemical sectors. In her pivotal role, Simone provides expert guidance on Chemistry, Manufacturing, and Controls (CMC) strategies, ensuring that Santhera’s innovative therapies meet global regulatory standards. Her responsibilities encompass authoring and reviewing critical CMC documentation for international submissions, including variations and amendments across diverse markets such as the EU, US, Asia, and South America, with a particular depth of expertise in Swiss regulatory requirements.

At Santhera, Simone plays a key role in overseeing the lifecycle management of the company’s products, from early development through registration and post-approval phases. Her deep understanding of regulatory pathways, combined with her proficiency in implementing HMV4 (Health Market Authorization Procedure 4) and other regulatory frameworks, ensures seamless compliance and efficient approval processes. She collaborates closely with cross-functional teams—regulatory, quality, manufacturing, and R&D—to align regulatory strategies with business objectives, fostering a culture of teamwork and open communication at all organizational levels.

Simone’s expertise in global variation filings and her ability to navigate complex regulatory landscapes make her an invaluable asset to Santhera’s mission to develop and deliver transformative therapies. Her commitment to maintaining high standards of compliance and her strategic approach to technical regulatory affairs underpin the company’s success in bringing innovative medicines to patients worldwide.