Senior Regulatory Affairs Lead - EU CTR/CTIS Strategy

Affinis Selección De Personal & Headhunting; Barcelona; On-site; EUR 90,000 - 120,000; Full time

Job summary

IQVIA seeks an experienced Regulatory Affairs professional to lead EU CTR/CTIS submissions and lifecycle activities. You will guide strategy, manage regulatory documentation, and liaise with authorities while mentoring juniors and supporting business development.

Ideal candidates have 8+ years in regulatory affairs within pharma/biotech/CRO sectors, with strong leadership and client-facing skills. Travel for meetings may be required.

Qualifications

• Bachelor's Degree in Life Sciences or related field required.
• Master's Degree preferred; advanced regulatory expertise expected.

Responsibilities

• Act as Regulatory Global Team Leader for regulatory projects.
• Lead preparation, review, and submission of regulatory docs.
• Provide strategic regulatory advice on EU submissions and lifecycle management.
• Lead EU CTR submissions and CTIS lifecycle activities.
• Manage communications with regulatory authorities and meetings.
• Build strong client relationships as regulatory advisor.

Skills

Regulatory leadership

EU CTR/CTIS strategy

Regulatory submissions

Client advisory

Project management

Stakeholder management

Budget and timelines

Regulatory intelligence

Education

Bachelor's in Life Sciences

Master's in Life Sciences (preferred)

Tools

CTIS

Regulatory systems

Job description

IQVIA seeks an experienced Regulatory Affairs professional to lead EU CTR/CTIS submissions and lifecycle activities. You will guide strategy, manage regulatory documentation, and liaise with authorities while mentoring juniors and supporting business development.

Ideal candidates have 8+ years in regulatory affairs within pharma/biotech/CRO sectors, with strong leadership and client-facing skills. Travel for meetings may be required.