Project Manager, Regulatory Affairs

Location: Budapest, Hungary

Time Type: Full time

Job Description

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 Project Manager, Regulatory Affairs to join our Global Regulatory Affairs team. In this role, you will lead the planning and delivery of regulatory affairs projects for global pharmaceutical, biotechnology and healthcare clients. Working closely with regulatory experts, clients and cross-functional teams, you will ensure projects are delivered efficiently, compliantly and to the highest quality standards. This role combines project leadership, client partnership and regulatory expertise. In addition to overseeing project delivery, you will support proposal development, bid activities and business growth initiatives across the European market.

What you'll do

• Lead regulatory affairs projects from initiation through completion, ensuring delivery on time, within scope, budget and quality expectations.
• Serve as the primary point of contact for clients on project delivery matters, fostering trusted partnerships through proactive communication and problem solving.
• Develop and maintain project plans, timelines, budgets, resource forecasts and governance structures.
• Coordinate cross-functional teams across regulatory strategy, regulatory operations, submissions, labeling, CMC, safety and other specialist disciplines.
• Monitor project progress, identify risks, issues and dependencies, and implement effective mitigation strategies.
• Ensure project deliverables meet applicable regulatory, quality and client requirements.
• Track project financials, resource utilization and overall project performance.
• Facilitate project governance meetings and provide clear status reporting to internal and external stakeholders.
• Support proposal development, bid responses, project scoping, resource estimates and client presentations.
• Build client solutions and lead new business proposal activities. 
• Collaborate with business development and subject matter experts to pursue new opportunities and support sustainable growth.
• Drive continuous improvement initiatives and share project management best practices across the organization.
• Foster a collaborative team environment through knowledge sharing, mentoring and effective stakeholder engagement.

What we're looking for

• Bachelor's degree in a life sciences discipline or equivalent combination of education and experience.
• Demonstrated experience managing projects within Regulatory Affairs, Regulatory Operations, Clinical Trial Submissions, Product Lifecycle Management, or a related pharmaceutical regulatory environment.
• Experience working within a CRO, pharmaceutical or biotechnology organization.
• Strong understanding of global regulatory processes, submission management and the drug development lifecycle.
• Proven ability to lead cross-functional and geographically dispersed teams.
• Experience managing project timelines, budgets, resources, risks and client expectations.
• Strong client-facing skills with the ability to build trusted stakeholder relationships.
• Experience contributing to proposals, bid responses, project scoping, resource planning and business development activities.
• Fluent English and good command of French.
• Excellent organizational, communication and problem-solving skills.
• Ability to manage multiple projects and priorities in a fast-paced, client-focused environment.
• PMP, PRINCE2 or other project management certification is advantageous.

Preferred

• Experience managing global or regional Regulatory Affairs programs.
• Experience supporting multiple concurrent projects within a consulting or CRO environment.
• Experience with Veeva Vault RIM, regulatory information management systems, or related regulatory technologies.
• Experience working with European regulatory procedures, clinical trial submissions, lifecycle management activities, and global Health Authority interactions.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.