Project Manager, Regulatory Affairs (Pharmaceutical Regulatory)

Location: Bucharest, Romania

Company

hirify.global provides clinical research services, commercial insights and healthcare intelligence for life sciences and healthcare organizations.

What you will do

• Lead regulatory affairs projects from initiation through completion, managing scope, timelines, budgets, resources and quality.
• Act as the primary client contact for delivery matters, communication and problem solving.
• Coordinate cross-functional teams across regulatory strategy, operations, submissions, labeling, CMC and safety.
• Monitor risks, issues, dependencies, financials and resource utilization, and implement mitigation plans.
• Facilitate governance meetings, prepare status reporting and ensure compliant project deliverables.
• Support proposals, bid responses, project scoping, client presentations and business development across Europe.

Requirements

• Bachelor’s degree in life sciences or an equivalent combination of education and experience.
• Experience managing projects in Regulatory Affairs, Regulatory Operations, Clinical Trial Submissions, Product Lifecycle Management or a related pharmaceutical regulatory environment.
• Experience in a CRO, pharmaceutical or biotechnology organization, including cross-functional and geographically dispersed teams.
• Strong understanding of global regulatory processes, submission management and the drug development lifecycle.
• Experience managing project plans, budgets, resources, risks, client expectations and business development activities.
• Fluent English and good command of French required.

Nice to have

• PMP, PRINCE2 or another project management certification.
• Experience with global or regional Regulatory Affairs programs and multiple concurrent projects.
• Experience with Veeva Vault RIM or related regulatory information management systems.
• Experience with European regulatory procedures, clinical trial submissions, lifecycle management and global Health Authority interactions.

Culture & Benefits

• Work with global pharmaceutical, biotechnology and healthcare clients.
• Collaborate with regulatory experts, business development specialists and cross-functional teams.
• Contribute to continuous improvement and share project management best practices.
• Support a collaborative environment through knowledge sharing, mentoring and stakeholder engagement.