Regulatory Affairs Project Lead (MAAs) Full Time

Responsibilities:

• Own the client relationship and communication.
• Cooperate with Finance Business Partner on systems.
• Work with Regulatory Affairs Lead/Technical Lead on plans.
• Provide proactive solutions for clients.
• Lead client kick-off meetings and discussions.
• Ensure project scope and expectations are clear.
• Manage project within budget and schedule.
• Maintain quality standards and comply with regulations.
• Take action to manage project deliverables.
• Oversee project budget and revenue recognition.
• Complete administrative project closeout procedures.
• Review project contract and team member suitability.
• Manage project team changes as needed.
• Participate in team kick-off meetings.

Requirements:

• University Degree in Scientific/Technical field.
• Advanced Degree preferred.
• Extensive Regulatory Affairs experience.
• CRO experience.
• MAA & Lifecycle submission expertise.
• Project management knowledge.
• Financial management skills.
• Strong communication skills.
• Fluent in English.

Benefits:

• Work remotely or from office locations.
• Opportunity to work on EU regulatory projects.
• Collaborate with diverse international teams.
• Contribution to global health improvement.