Associate Regulatory Affairs Director, Europe SME

About the role

iQVIA's Global Regulatory Affairs team partners with pharmaceutical and biotechnology companies worldwide to navigate complex regulatory environments and accelerate patient access to innovative therapies. It is seeking an experienced Associate Director, Regulatory Affairs to lead European regulatory activities and build and develop a team of regulatory professionals across the region. The role suits someone combining deep European regulatory knowledge with a passion for people leadership and client partnership.

Key responsibilities

• Lead and oversee complex European regulatory activities across the product lifecycle, including market applications, lifecycle management and post-marketing submissions
• Provide strategic guidance on European regulatory procedures, including Centralised, Decentralised, Mutual Recognition and National procedures
• Act as a trusted regulatory advisor to clients, supporting regulatory strategy, governance discussions and decision-making
• Contribute to proposal development, bid defense meetings and business growth initiatives
• Lead, coach and develop Regulatory Affairs professionals within a global matrix environment
• Support resource planning, forecasting and operational excellence initiatives
• Drive continuous improvement while ensuring high-quality regulatory delivery

Required profile

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Chemistry or a related discipline
• Extensive Regulatory Affairs experience with strong knowledge of European regulatory requirements and submission pathways
• Significant people management and leadership experience
• Experience supporting marketed products, post-marketing activities and lifecycle management
• Proven success managing complex regulatory programmes and stakeholder relationships

Required skills

• Strong communication and presentation skills, able to influence internal and external stakeholders
• Commercial awareness and interest in proposal development and business growth
• Nice to have: experience with biologics products, CRO, consultancy or client-facing Regulatory Affairs experience, and participation in proposal development or bid defense activities

The role offers broad exposure to regulatory strategy, commercial partnership and leadership opportunities, with potential progression into broader Global Regulatory Affairs leadership positions. Applications are made through the iQVIA careers site.