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A dynamic clinical research organization is seeking a Regulatory Affairs Project Manager to lead internal projects for their international clients from various European locations. The role involves managing client relationships, project execution, and compliance with regulatory standards while requiring a solid background in Regulatory Affairs and project management. Candidates should have a relevant degree and substantial experience in the industry, with excellent communication and financial management skills. This position can be home or office-based, catering to diverse work preferences.
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.
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.
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
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