Alvotech

The Director of Statistical Programming will lead the biometrics programming strategy and oversee the execution of statistical deliverables for clinical trials. This role involves managing a team of programmers, ensuring compliance with regulatory standards, and collaborating with cross-functional departments to support drug development programs.

The Master Data Lead will own and champion data quality standards across SAP and associated systems to ensure integrity, accuracy, and consistency. They will also define governance frameworks and facilitate data stewardship across procurement, finance, and operations functions.

Develop and implement global regulatory strategies for post-approval CMC changes and manage the submission of regulatory filings. Serve as a key contact for health authorities and collaborate with cross-functional teams to ensure product supply continuity.

Manage post-approval CMC regulatory filings and evaluate the regulatory impact of manufacturing changes. Collaborate with cross-functional teams to maintain regulatory dossiers and respond to health authority queries.