Associate Program Director, Regulatory Affairs

About the role

IQVIA is looking for an experienced Associate Program Director, Regulatory Affairs to join its Global Regulatory Affairs team in Eastern Europe. This senior, client-facing role leads complex global regulatory programs for pharmaceutical, biotechnology and healthcare clients across the product development lifecycle, overseeing multiple workstreams, driving program governance and managing client relationships at senior level.

Key responsibilities

• Lead complex global regulatory programs and act as a strategic partner and senior point of contact for clients
• Establish program governance, oversight plans, KPIs and delivery frameworks
• Drive program planning, financial management, forecasting, resource strategy and execution
• Oversee cross-functional teams covering Regulatory Strategy, Regulatory Operations, Submissions, Labeling, CMC, Safety, Regulatory Intelligence and Lifecycle Management
• Identify risks and opportunities, monitor profitability and revenue realization, and lead governance meetings and executive business reviews
• Partner with Business Development and consulting teams to develop client solutions, lead proposal development, bid defense and pricing discussions
• Mentor project managers and team members and drive continuous improvement in regulatory program management

Required profile

• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs or a related field; advanced degree preferred
• Significant experience in regulatory affairs, regulatory operations or regulatory strategy
• Proven track record leading large, complex global programs in a CRO, pharma or biotech environment
• Professional fluency in English and French, including client meetings and business development
• Experience managing complex client engagements, cross-functional and geographically dispersed teams, and program budgets and forecasts
• Proven contribution to proposals, bid defenses and client presentations

Required skills

• Strong understanding of global regulatory frameworks, submission management and drug development processes
• PMP, PRINCE2 or equivalent project/program management certification is advantageous
• Preferred: experience with Veeva Vault RIM, European regulatory procedures and Clinical Trial Applications, and knowledge of digital regulatory technologies and AI-enabled regulatory solutions