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Senior Regulatory Affairs & Pharmacovigilance Specialist
PQE Group
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remote, Spain
Location
remote
Posted
June 07, 2026
Commute
Local Area
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Job Description
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 1β5) from scratch Manage variations, renewals, labeling updates , and Health Authority interactions Support regulatory activities in LATAM markets Collaborate with global teams and international clients Pharmacovigilance (PV): Support PV activities and reporting obligations in Spain and E...