EU Regulatory Lead: CTR/CTIS & Clinical Trials

Iqvia Argentina; Viseu; Presencial; EUR 90 000 - 130 000; Tempo integral

Resumo da oferta

IQVIA is seeking an experienced Regulatory affairs professional to lead EU CTR submissions, CTIS lifecycle activities, and regulatory strategy for multinational trials. The role requires advancing regulatory documentation quality, interacting with RMS and agencies, and guiding clients through submission planning and lifecycle management.

Applicants should have a minimum of 8 years in regulatory affairs within pharma/biotech/CRO, with 2–3 years in EU CTR/CTIS, and experience mentoring colleagues.

Qualificações

• Bachelor's Degree in Life Sciences or related discipline required
• Master's Degree in Life Sciences or related discipline preferred
• Minimum of 8 years of regulatory affairs experience in pharma/biotech/CRO
• Minimum of 2–3 years hands-on EU CTR and CTIS experience
• Experience with CTIS lifecycle activities including RFIs and substantial modifications
• Experience interacting with RMS and European authorities
• Strong regulatory strategy, timelines, budget management, and doc gap assessment
• Proficiency with MS Office and regulatory publishing tools

Responsabilidades

• Lead preparation, review, and submission of regulatory documentation
• Provide strategic regulatory advice to clients (EU submission strategy, RMS selection)
• Lead and support EU CTR submissions and CTIS lifecycle activities
• Manage communications with regulatory authorities and participate in agency meetings
• Mentor junior colleagues and support training and development
• Support business development, bid defenses, and client presentations
• Develop and review regulatory SOPs and participate in global initiatives

Conhecimentos

Regulatory leadership

Strategic regulatory advice

Regulatory project management

Communication excellence

Microsoft Office proficiency

Formação académica

Bachelor's Degree in Life Sciences

Master's Degree in Life Sciences (preferred)

Ferramentas

Regulatory systems

Publishing tools

Descrição da oferta de emprego

IQVIA is seeking an experienced Regulatory affairs professional to lead EU CTR submissions, CTIS lifecycle activities, and regulatory strategy for multinational trials. The role requires advancing regulatory documentation quality, interacting with RMS and agencies, and guiding clients through submission planning and lifecycle management.

Applicants should have a minimum of 8 years in regulatory affairs within pharma/biotech/CRO, with 2–3 years in EU CTR/CTIS, and experience mentoring colleagues.