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