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Regulatory Affairs Project Manager

Regulatory Affairs Project Manager

ParexelRemote, Romania
30+ days ago
Job description

When our values align, there's no limit to what we can achieve.

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

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Project Manager • Remote, Romania

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