Regulatory Affairs Project Lead MAAs

• Own the client relationship and responsibility for client communication ensuring high client satisfaction
• Cooperates with the Finance Business Partner to ensure that any systems and system interfaces are functioning
• Work with RAL and /or TL to provide initial schedule and resource plan to GRT
• Pro-active approach to providing solution set for clients
• Lead client kick off meeting and discussions with client, establishing client expectations for project delivery, communication, and client specific metrics
• Ensure the scope of the project is well understood by the project team and set the team expectations
• Manage the project such that it is completed within budget, schedule and according to contract specifications
• Ensure the project is progressing according to quality standards, SOPs, and to fulfil local regulations
• Proactively take action where required to maintain project deliverables, to effectively manage the project’s critical path, resourcing, metrics compliance, the budget and third party vendors
• Manage the project budget with the Finance Business Partner including the completion of monthly revenue recognition, forecasting and cost management
• Oversee all administrative closeout procedures are completed, according to Project Closeout Checklist
• Review the project contract exhibit and ensure relevant team members have received it
• Manage the set-up of the project team, oversee request for resources, review proposed team members for suitability and manage any project team changes throughout the duration of the project
• Review initial budget request with SC/CXD for any project specific adaptations
• Participate in or manage the team kick-off meeting

• University Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
• Extensive years of Regulatory Affairs experience in an industry-related environment
• Experience in MAA preparation and submissions
• CRO experience
• Project management knowledge and experience
• Financial management skills
• Excellent interpersonal and intercultural communication skills, both written and verbal
• Fluent in English

PMP or equivalent

• Flexible Work Program
• Bravo Recognition Program
• Supportive and inclusive environment
• Opportunities for career growth
• Flexible work arrangements
• Diverse and global client exposure
• Learn from experts