EU Regulatory Lead: CTR/CTIS & Lifecycle Expert

IQVIA; Oeiras; Presencial; EUR 90 000 - 130 000; Tempo integral

Resumo da oferta

IQVIA is seeking an experienced Regulatory Affairs professional to provide strategic leadership for EU CTR submissions and CTIS management. The role focuses on regulatory strategy, high-quality documentation, and lifecycle activities across multiple trials.

Ideal candidates have 8+ years in regulatory affairs, with 2–3 years hands-on CTIS experience, RMS interactions, and strong client-facing communication. A Master’s degree is preferred and travel for bid defenses may be required.

Qualificações

• Minimum 8 years of regulatory affairs experience in pharma, biotech, CRO, or related industry.
• 2–3 years hands-on EU CTR and CTIS experience, including preparation and submission of Part I CTAs.
• Experience managing CTIS lifecycle activities, RFIs, substantial modifications, and ongoing trial maintenance.
• Experience interacting with RMS and other European regulatory authorities.
• Proven ability to advise clients on EU regulatory strategy and submission planning.

Responsabilidades

• Act as Regulatory Global Team Leader or Regulatory Project Manager on projects.
• Lead preparation, review, and submission of regulatory documentation with high quality and compliance.
• Provide strategic regulatory advice for EU submissions, RMS planning, and lifecycle management.
• Lead EU CTR submissions including CTIS lifecycle activities and RFIs.
• Manage communications with regulatory authorities and participate in agency meetings.
• Build client relationships as a trusted regulatory advisor and manage project timelines, budgets, and throughput.
• Mentor junior colleagues and support training and professional development.
• Support business development activities including bid defenses and client presentations.

Conhecimentos

Regulatory leadership

EU CTR submissions

CTIS management

Regulatory strategy

Regulatory documentation

Stakeholder management

Project management

Communication

Microsoft Office

Regulatory systems

Formação académica

Bachelor's Degree in Life Sciences

Master's Degree in Life Sciences

Ferramentas

CTIS

Regulatory systems

Descrição da oferta de emprego

IQVIA is seeking an experienced Regulatory Affairs professional to provide strategic leadership for EU CTR submissions and CTIS management. The role focuses on regulatory strategy, high-quality documentation, and lifecycle activities across multiple trials.

Ideal candidates have 8+ years in regulatory affairs, with 2–3 years hands-on CTIS experience, RMS interactions, and strong client-facing communication. A Master’s degree is preferred and travel for bid defenses may be required.