Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas. We are looking for a Regulatory Affairs Specialist to join our team and support regulatory activities across EMEA and LATAM. This position is idóneo for a professional with around 3 years of experience in Regulatory Affairs , particularly with strong exposure to CMC documentation and lifecycle management in multinational environments. We offer a full-time employment contract based in Madrid , starting with a one-year fully remote assignment on an international project, including occasional travel to the client's site in Alcobendas during the first year. Responsibilities include, but are not limited to: Support regulatory submissions and activities across EMEA and LATAM markets. Prepare and maintain regulatory dossiers , including Module 1 and Module 3 documentation.



Contribute to CMC regulatory strategies and documentation. Manage lifecycle activities , including variations, renewals, and post-approval changes. Prepare and review technical documentation such as ASMF and Quality Overall Summary (Qo S). Coordinate regulatory submissions and ensure compliance with regional regulatory requirements. Support interactions with health authorities and assist in addressing regulatory queries. Collaborate with cross-functional and international teams in a multinational environment. Required Qualifications: Around 3 years of experience in Regulatory Affairs within the pharmaceutical industry. Strong knowledge of CMC documentation and regulatory dossier preparation (Modules 1 & 3). Experience with lifecycle management , including variations and renewals. Familiarity with ASMF and Qo S documentation. Experience supporting multi-region regulatory submissions , preferably across EMEA and/or LATAM. Ability to w

📌 Regulatory affairs specialist (Santander)
🏢 Pqe Group
📍 Santander