We are seeking a dynamic and experienced Regulatory Affairs Project Manager to join our team. This role offers the flexibility of being home or office-based in various European countries.
About the Role:
As a Regulatory Affairs Project Manager, you will be at the forefront of leading internal projects for Parexel clients. You will provide a broad range of consulting services, working within project guidelines to identify, refine, and address client issues while achieving project objectives.
Key Responsibilities:
* Own client relationships and ensure high client satisfaction through effective communication
* Lead project initiation, execution, control, and closure processes
* Manage projects to completion within budget, schedule, and contract specifications
* Oversee resource planning, team management, and budget control
* Ensure compliance with quality standards, SOPs, and local regulations
* Provide guidance to project team members on technical and process issues
Qualifications:
* University Degree in a Scientific or Technical Discipline (Advanced Degree preferred)
* Extensive experience in Regulatory Affairs within an industry-related environment
* Good understanding and hands on experience of marketing authorisation application (MAA) process
* Strong project management skills (PMP or equivalent certification is a plus)
* CRO experience
* Excellent financial management skills
* Outstanding interpersonal and intercultural communication skills, both written and verbal
* Fluency in English