Regulatory Affairs Project reputed company MAAs (home or office based)

This a Full Remote job, the offer is available from: Hungary, Poland, Romania, Czechia, Serbia, Oregon (USA) reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in reputed company do. Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. External Job Description We are currently looking for a Senior Regulatory Affairs Consultant (Project reputed company)! As a Senior Consultant you will be responsible for leading internal projects on behalf of reputed company Clients. A Senior Consultant provides a broad range of consulting services and works reputed company project guidelines to identify, refine, and address client issues and to reputed company project objectives. We are looking for an reputed company candidate with strong organizational skills, the ability to prioritise and influence internal teams, as well as developing client relationships. You will provide guidance to project team members on technical/process issues. In this role you will have solid EU regulatory experience, e.g., MAA preparation and submission. This role can be located in various European countries, home or office based. Job Responsibilities:

• Project Initiation Management:
• 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
• Project Execution Management:
• reputed company 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
• Project Implementation, Control & Evaluation:
• Manage the project such that it is completed reputed company 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 reputed company recognition, forecasting and cost management
• Project Closure Management:
• reputed company reputed company 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, reputed company 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

Skills and Experience required for the role:

• University Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
• PMP or equivalent - reputed company to have
• Extensive years of Regulatory Affairs experience in an industry-reputed company 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

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