Senior Global Regulatory Programs Lead

IQVIA LLC; Warszawa; On-site; PLN 221,000 - 469,000; Full time

Job summary

IQVIA Warsaw seeks an experienced Associate Program Director, Regulatory Affairs to lead complex global regulatory programs across pharmaceutical and biotech clients in Eastern Europe. You will serve as a senior leader, overseeing multiple workstreams, guiding governance, and partnering with regulatory experts to deliver scalable solutions.

In this client-facing role, you will manage budgets, forecast resources, and drive improvements while building long-term strategic relationships.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs or a related discipline.
• Advanced degree preferred.
• PMP, PRINCE2 or equivalent project/program management certification is advantageous.

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, utilization and revenue realization, taking corrective action where needed.

Skills

Regulatory affairs

Program management

Client relationship management

Strategic leadership

Cross-functional leadership

Financial acumen

Stakeholder management

English

French

Veeva Vault RIM

Regulatory submissions

Life sciences

PMP/PRINCE2

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

PM Certification (PMP/PRINCE2) advantageous

Tools

Veeva Vault RIM

RIM systems

Digital regulatory technologies

Job description

IQVIA Warsaw seeks an experienced Associate Program Director, Regulatory Affairs to lead complex global regulatory programs across pharmaceutical and biotech clients in Eastern Europe. You will serve as a senior leader, overseeing multiple workstreams, guiding governance, and partnering with regulatory experts to deliver scalable solutions.

In this client-facing role, you will manage budgets, forecast resources, and drive improvements while building long-term strategic relationships.