Senior Regulatory Affairs & Pharmacovigilance Specialist

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 seeking a Senior Regulatory Affairs & Pharmacovigilance Specialist to support both local and international regulatory and PV activities. The role combines hands-on regulatory work with pharmacovigilance oversight, ensuring compliance across Spain and LATAM markets.

Key Responsibilities

Regulatory Affairs (RA)

• Analyze EU regulatory strategies and provide recommendations to clients
• Author full technical dossiers (Modules 1–5) from scratch
• Manage variations, renewals, labeling updates , and Health Authority interactions
• Support regulatory activities in LATAM markets
• Collabora...