Senior Regulatory Affairs & Pharmacovigilance Specialist (Barcelona)

Role Overview

Senior Regulatory Affairs & Pharmacovigilance Specialist to support local and international regulatory and PV activities in 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 EU.
  • Ensure compliance with local and international safety regulations.
  • Assist in signal detection, risk management, and safety documentation.
  • Coordinate with general PV teams to align processes and reporting.

Req...