Senior Regulatory Affairs Consultant (Project Lead)

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds 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 were 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 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:

• 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 projects 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 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

• 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