Regulatory Affairs Manager

About the role

IQVIA is looking for a Regulatory Affairs Manager in Madrid, an independent contributor with at least 8 years of relevant industry experience. The role provides strategic regulatory expertise and leadership for clinical trial applications and lifecycle management, with a strong focus on EU Clinical Trials Regulation (CTR) submissions and CTIS management.

Key responsibilities

• Act as Regulatory Global Team Leader for regulatory projects and/or Regulatory Project Manager for stand-alone projects
• Prepare, review and submit regulatory documentation in line with regulations and guidelines
• Advise clients on EU submission strategy, Reporting Member State selection, scientific advice planning and lifecycle management
• Lead EU CTR submissions, including initial CTAs, substantial modifications, RFIs and CTIS activities
• Communicate with regulatory authorities, including agency meetings
• Maintain client relationships and resolve issues proactively
• Manage project timelines, deliverables, budgets and out-of-scope activities
• Mentor junior colleagues and support training and professional development
• Support business development, including bid defence meetings and client presentations
• Review regulatory SOPs and contribute to global, regional and cross-functional regulatory initiatives

Required profile

• Bachelor's degree in Life Sciences or a related discipline; Master's preferred
• At least 8 years of regulatory affairs experience in pharma, biotech, CRO or related industry
• 2 to 3 years of hands-on EU CTR and CTIS experience, including Part I initial CTAs
• Experience with RMS and other European regulatory authorities
• Experience advising clients on EU regulatory strategy
• Ability to manage multiple projects and priorities independently

Required skills

• Strong understanding of EU clinical trial regulations, CTIS requirements and regulatory documentation
• Project leadership, stakeholder management and excellent written and verbal communication
• Microsoft Office and relevant regulatory systems and publishing tools