Senior Regulatory Affairs Lead — EU CTR/CTIS Expert

Affinis Selección De Personal E Headhunting; Madrid; Vor Ort; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

IQVIA in Madrid seeks an experienced Regulatory Affairs professional to lead EU submissions and lifecycle management for clinical trials. You will act as Regulatory Global Team Leader, guide strategy, and coordinate CTIS activities, ensuring compliance and timely delivery across projects.

The role requires 8+ years in regulatory affairs in pharma/biotech/CRO, strong client advisory skills, and ability to mentor juniors while supporting business development and SOP improvements.

Qualifikationen

• Bachelor's Degree in Life Sciences or related field.
• 8+ years regulatory affairs experience in pharma/biotech/CRO.
• 2–3 years EU CTR/CTIS hands-on experience incl CTAs.
• Experience with CTIS lifecycle and RMS interactions.
• Strong regulatory strategy, timelines, and budgets.

Aufgaben

• Act as Regulatory Global Team Leader for regulatory projects and/or serve as Regulatory Project Manager for stand-alone projects.
• Lead the preparation, review, and submission of regulatory documentation for high quality submissions.
• Provide strategic regulatory advice to clients, including EU submission strategy and RMS selection.
• Lead EU CTR submissions and CTIS lifecycle activities (RFIs, substantial modifications).
• Manage communications with regulatory authorities and participate in agency meetings.
• Build and maintain strong client relationships as a regulatory advisor.
• Oversee timelines, budgets, and out-of-scope activities for project success.
• Mentor junior colleagues and support training and development.
• Support business development, including client presentations and bid defense.

Kenntnisse

Regulatory strategy

EU CTR & CTIS

Regulatory submissions

Project leadership

Client relationships

Regulatory documentation

Budget management

Timeline management

Mentoring juniors

Stakeholder management

Ausbildung

Bachelor's in Life Sciences

Master's in Life Sciences (preferred)

Jobbeschreibung

IQVIA in Madrid seeks an experienced Regulatory Affairs professional to lead EU submissions and lifecycle management for clinical trials. You will act as Regulatory Global Team Leader, guide strategy, and coordinate CTIS activities, ensuring compliance and timely delivery across projects.

The role requires 8+ years in regulatory affairs in pharma/biotech/CRO, strong client advisory skills, and ability to mentor juniors while supporting business development and SOP improvements.