At IQVIA, we help life sciences organizations accelerate the development and commercialization of innovative therapies that improve patient outcomes worldwide.
We are seeking an experienced Associate Program Director, Regulatory Affairs to join our Global Regulatory Affairs team in Eastern Europe. In this strategic client-facing role, you will lead complex global regulatory programs for pharmaceutical, biotechnology and healthcare clients, ensuring the successful delivery of regulatory solutions across the product development lifecycle.
As a senior leader within our Regulatory Affairs organization, you will oversee multiple regulatory workstreams, drive program governance, manage client relationships at senior levels and collaborate with regulatory experts to develop innovative, scalable solutions. You will serve as a trusted partner to clients, balancing operational excellence, financial performance and strategic growth opportunities while helping shape the future of IQVIA's Regulatory Affairs business.
This position offers the opportunity to work across diverse regulatory disciplines, engage with global stakeholders and contribute directly to business expansion through consulting, proposal development and strategic client engagement.
What You'll Do
Lead complex global Regulatory Affairs programs, ensuring successful delivery across multiple projects, workstreams and functional teams.
Act as a strategic partner and senior point of contact for clients, providing program leadership and executive-level stakeholder management.
Establish and maintain program governance structures, oversight plans, KPIs and delivery frameworks.
Drive program planning, financial management, forecasting, resource strategy and operational execution.
Oversee cross-functional regulatory teams spanning Regulatory Strategy, Regulatory Operations, Submissions, Labeling, CMC, Safety, Regulatory Intelligence and Lifecycle Management.
Identify program risks, dependencies and opportunities, developing proactive mitigation and escalation strategies.
Ensure delivery of high-quality regulatory solutions that meet client objectives, business requirements and regulatory expectations.
Monitor program performance, profitability, utilization and revenue realization, taking corrective action where needed.
Lead governance meetings, steering committees and executive business reviews with clients and senior internal stakeholders.
Provide strategic oversight and guidance on regulatory delivery models, resourcing approaches and operational best practices.
Partner with Business Development, Consulting and Subject Matter Experts to develop client solutions and expand existing relationships.
Lead proposal development, bid defense activities, scope definition, pricing discussions and resource planning for new opportunities.
Identify opportunities for account growth and contribute to the expansion of IQVIA's Global Regulatory Affairs offerings.
Mentor project managers and other team members, promoting knowledge sharing, capability development and delivery excellence.
Drive continuous improvement initiatives and contribute to the evolution of regulatory program management practices across the organization.
What We're Looking For
Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs or a related discipline. Advanced degree preferred.
Significant experience within Regulatory Affairs, Regulatory Operations, Regulatory Strategy or related pharmaceutical regulatory functions.
Proven experience leading large, complex global programs or portfolios within a CRO, pharmaceutical or biotechnology environment.
Strong understanding of global regulatory frameworks, submission management, product lifecycle management and drug development processes.
Professional fluency in English and French is required, including the ability to lead client meetings, manage complex stakeholder discussions and contribute to business development activities in both languages.
Demonstrated success…