EU Regulatory Affairs Lead: CTR & CTIS Expert

IQVIA; Madrid; On-site; EUR 70,000 - 90,000; Full time

Job summary

IQVIA is seeking an experienced Regulatory Affairs professional in Madrid, Spain to lead and manage EU CTR submissions and CTIS lifecycle activities. You will provide strategic regulatory guidance, interact with regulatory authorities, and mentor junior staff while ensuring timely, compliant deliverables.

The role requires 8+ years in regulatory affairs within pharma/biotech/CRO, with hands-on EU CTR/CTIS experience and RMS interactions.

Qualifications

• Bachelor's Degree in Life Sciences or related discipline required.
• Master's Degree preferred.
• 8+ years regulatory affairs experience in pharma/biotech/CRO.
• 2–3 years hands-on EU CTR/CTIS experience and CTIS lifecycle management.
• Experience with RMS interactions and EU regulatory strategy.

Responsibilities

• Act as Regulatory Global Team Leader or Regulatory Project Manager for projects.
• Lead preparation, review, and submission of regulatory docs to ensure compliance.
• Provide strategic regulatory advice including EU submission strategy and RMS selection.
• Lead EU CTR submissions and CTIS lifecycle activities (RFIs, modifications).
• Manage communications with regulatory authorities and participate in agency meetings.
• Build client relationships and act as trusted regulatory advisor.
• Oversee timelines, budget, and out‑of‑scope work; mentor junior staff.

Skills

Regulatory leadership

Regulatory strategy

EU CTR submissions

CTIS management

Regulatory documentation

Client advisory

Regulatory authorities

Project management

Education

Bachelor Life Sciences

Master Life Sciences

Tools

CTIS

Regulatory systems

MS Office

Job description

IQVIA is seeking an experienced Regulatory Affairs professional in Madrid, Spain to lead and manage EU CTR submissions and CTIS lifecycle activities. You will provide strategic regulatory guidance, interact with regulatory authorities, and mentor junior staff while ensuring timely, compliant deliverables.

The role requires 8+ years in regulatory affairs within pharma/biotech/CRO, with hands-on EU CTR/CTIS experience and RMS interactions.