Regulatory Affairs Project Lead (MAAs)

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all 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 what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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