When our values align, there's no limit to what we can achieve.
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, e.g., MAA preparation and submission.
This role can be located in various European countries, home or office based.
Job Responsibilities:
1. Project Initiation Management:
2. Own the client relationship and responsibility for client communication ensuring high client satisfaction
3. Cooperates with the Finance Business Partner to ensure that any systems and system interfaces are functioning
4. Work with RAL and /or TL to provide initial schedule and resource plan to GRT
5. Pro-active approach to providing solution set for clients
6. Project Execution Management:
7. 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
8. Project Implementation, Control & Evaluation:
9. Manage the project such that it is completed within budget, schedule and according to contract specifications
10. Ensure the project is progressing according to quality standards, SOPs, and to fulfil local regulations
11. 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
12. Manage the project budget with the Finance Business Partner including the completion of monthly revenue recognition, forecasting and cost management
13. Project Closure Management:
14. Oversee all administrative closeout procedures are completed, according to Project Closeout Checklist
15. Review the project contract exhibit and ensure relevant team members have received it
16. 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.
17. Review initial budget request with SC/CXD for any project specific adaptations
18. Participate in or manage the team kick-off meeting
Skills and Experience required for the role:
19. University Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
20. PMP or equivalent - nice to have
21. Extensive years of Regulatory Affairs experience in an industry-related environment
22. Experience in MAA preparation and submissions
23. CRO experience
24. Project management knowledge and experience
25. Financial management skills
26. Excellent interpersonal and intercultural communication skills, both written and verbal
27. Fluent in English