EU Regulatory Affairs Lead - CTR/CTIS Expert

IQVIA; Barcelona; On-site; EUR 120,000 - 160,000; Full time

Benefits offered by this job

Restaurant d'entreprise

Job summary

IQVIA is seeking a regulatory expert with extensive experience to provide senior guidance on EU CTR submissions and CTIS management. This individual will lead regulatory projects, prepare and submit regulatory documentation, and advise clients on submission strategy and lifecycle management.

With at least 8 years in regulatory affairs and 2–3 years specifically in EU CTR/CTIS, the role involves coordinating with RMS and authorities, mentoring colleagues, and supporting business development and

Qualifications

• Minimum of 8 years of regulatory affairs experience within pharma/biotech/CRO.
• 2–3 years hands-on EU CTR and CTIS experience with CTA submissions.
• Experience managing CTIS lifecycle activities and RMS interactions.

Responsibilities

• Lead regulatory projects and serve as Regulatory Project Manager on stand-alone projects.
• Lead preparation, review, and submission of regulatory documentation for EU CTR/CTIS.
• Provide strategic regulatory advice including submission strategy and lifecycle management.
• Lead EU CTR submissions including RFIs and CTIS activities.
• Manage communications with regulatory authorities and agency meetings.
• Build client relationships and act as regulatory trusted advisor.
• Manage project timelines, budgets, and out-of-scope activities.
• Mentor junior colleagues and support training and development.
• Support business development with bid defenses and client presentations.
• Contribute to SOPs and cross-functional regulatory initiatives.

Skills

Regulatory leadership

EU CTR experience

CTIS management

Regulatory documentation

Client communication

Project leadership

Education

Bachelor's Degree in Life Sciences

Master's Degree in Life Sciences

Tools

Microsoft Office

Regulatory systems

Publishing tools

Job description

IQVIA is seeking a regulatory expert with extensive experience to provide senior guidance on EU CTR submissions and CTIS management. This individual will lead regulatory projects, prepare and submit regulatory documentation, and advise clients on submission strategy and lifecycle management.

With at least 8 years in regulatory affairs and 2–3 years specifically in EU CTR/CTIS, the role involves coordinating with RMS and authorities, mentoring colleagues, and supporting business development and