Regulatory Affairs Project Lead (MAAs)
Romania, Remote Job ID R0000029025 Category Consulting Date Posted 11/28/2024Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
We are currently looking for a Senior Regulatory Affairs Consultant (Project Lead)! As a Senior Consultant you will be responsible for leading internal projects on behalf of Parexel Clients. A Senior Consultant provides a broad range of consulting services and works within project guidelines to identify, refine, and address client issues and to achieve project objectives. We are looking for an experienced 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 (predominantly for post approval submissions for mature products portfolios).
The role can be home or office based in various European locations.
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 Regulatory Affairs Lead and /or TL Technical Lead to provide initial schedule and resource plan to Global Resourcing Team GRT
Pro-active approach to providing solution set for clients
Project Execution Management:
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
Project Implementation, Control & Evaluation:
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
Project Closure 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 Program Director 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 - nice to have
Extensive years of Regulatory Affairs experience in an industry-related environment
CRO experience
Experience in MAA & Lifecycle maintenance activities preparation and submissions
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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