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 Collaborate with global teams and international clients Pharmacovigilance (PV): Support PV activities and reporting obligations in Spain and E...

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