Description
IQVIA is seeking an experienced Associate Program Director, Regulatory Affairs to join our Global Regulatory Affairs team in Eastern Europe. As a senior leader within our Regulatory Affairs organisation, 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.
Responsibilities
- 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, utilisation and revenue realisation, 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 defence 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 organisation.
Requirements
- 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 managing complex client engagements and building long-term strategic partnerships.
- Experience leading cross-functional and geographically dispersed teams in matrix environments.
- Strong financial acumen with experience managing program budgets, revenue forecasts, profitability and resource planning.
- Experience overseeing multiple concurrent projects, priorities and stakeholders.
- Proven contribution to business development activities including proposals, bid defences, solution design and client presentations.
- Excellent communication, negotiation and influencing skills, including experience engaging executive-level stakeholders.
- Strong analytical, problem-solving and decision-making capabilities.
- PMP, PRINCE2 or equivalent project/program management certification is advantageous.
Preferred
- Experience leading global or regional Regulatory Affairs programs for large pharmaceutical or biotechnology organisations.
- Experience managing strategic accounts and long-term client partnerships.
- Regulatory consulting experience within a CRO or professional services environment.
- Experience with Veeva Vault RIM, Regulatory Information Management systems and digital regulatory technologies.
- Experience supporting European regulatory procedures, Clinical Trial Applications, lifecycle management and global Health Authority interactions.
- Knowledge of emerging regulatory trends, digital transformation and AI-enabled regulatory solutions.
- Experience participating in organisational growth initiatives, capability development or practice leadership.