EU Regulatory Affairs Lead: CTR/CTIS Strategy & Submissions

IQVIA; Madrid; Presencial; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

IQVIA is seeking an experienced Regulatory Affairs professional to lead EU CTR submissions and CTIS lifecycle activities. This role focuses on strategic regulatory leadership for clinical trial applications and lifecycle management across global teams.

Required are at least 8 years in regulatory affairs, deep EU regulatory knowledge, and the ability to manage multiple projects, budgets, and client interactions while mentoring junior colleagues. On-site in Madrid, Spain.

Formación

• Bachelor's degree in Life Sciences or related field required.
• Master's degree preferred.
• Minimum 8 years regulatory affairs experience in pharma/biotech/CRO.

Responsabilidades

• Act as Regulatory Global Team Leader for projects.
• Lead preparation, review, and submission of regulatory docs for compliance.
• Provide strategic regulatory advice to clients on EU submissions.
• Lead EU CTR submissions and CTIS lifecycle activities.
• Manage communications with regulatory authorities and meetings.
• Build client relationships and resolve regulatory issues.
• Oversee timelines, budgets, and out-of-scope work.
• Mentor junior colleagues and support training.

Conocimientos

Regulatory leadership

Project management

Client advisory

Stakeholder mgmt

Regulatory writing

EU CTR/CTIS knowledge

Regulatory strategy

Cross-functional collaboration

Educación

Bachelor's in Life Sciences

Master's in Life Sciences (preferred)

Herramientas

Regulatory systems

Publishing tools

Microsoft Office

Descripción del empleo

IQVIA is seeking an experienced Regulatory Affairs professional to lead EU CTR submissions and CTIS lifecycle activities. This role focuses on strategic regulatory leadership for clinical trial applications and lifecycle management across global teams.

Required are at least 8 years in regulatory affairs, deep EU regulatory knowledge, and the ability to manage multiple projects, budgets, and client interactions while mentoring junior colleagues. On-site in Madrid, Spain.