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