Senior Regulatory Affairs Consultant – Project Lead

This is a fully remote position, open to applicants in Romania.

📋 Description

• Take ownership of the client relationship and manage client communications to ensure a high level of client satisfaction.

• Collaborate with the Finance Business Partner to ensure the smooth functioning of systems and system interfaces.

• Partner with RAL and/or TL to develop the initial schedule and resource plan for GRT.

• Lead the client kickoff meeting and engage in discussions with the client to set clear expectations for project delivery, communication, and client-specific metrics.

• Oversee the project to ensure completion within budget, timeline, and in accordance with contract specifications.

• Ensure the project progresses in line with quality standards, SOPs, and local regulations.

• Proactively address any issues to maintain project deliverables, effectively manage the project's critical path, resource allocation, metric compliance, budget, and third-party vendors.

• Manage the project budget alongside the Finance Business Partner, which includes monthly revenue recognition, forecasting, and cost management.

• Ensure all administrative closeout procedures are finalized according to the Project Closeout Checklist.

• Facilitate the setup of the project team, oversee resource requests, assess proposed team members for suitability, and manage any changes to the project team throughout the project duration.

⛳️ Requirements

• Bachelor's Degree in a Scientific or Technical Field; an Advanced Degree is preferred.

• PMP certification or equivalent is a plus.

• Significant years of experience in Regulatory Affairs within a relevant industry context.

• Experience in preparing and submitting Marketing Authorization Applications (MAA).

• Experience working with Contract Research Organizations (CRO).

• Knowledge and experience in project management.

• Strong financial management skills.

• Exceptional interpersonal and intercultural communication skills, both written and verbal.

• Proficient in English.

🏝️ Benefits

• Health insurance coverage.

• Paid time off.

• Opportunities for professional development.