Regulatory Affairs Project Management Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeProject Full time €90,000 - €110,000

Unlock Your Potential as a Regulatory Affairs Project Manager

This role offers the flexibility of working from home or office in various European countries.

About the Role:

As a Regulatory Affairs Project Manager, you will lead internal projects for clients, providing a broad range of consulting services. You will work within project guidelines to identify, refine, and address client issues while achieving project objectives.

Key Responsibilities:
  • Build strong relationships with clients and ensure their satisfaction through effective communication
  • Lead project initiation, execution, control, and closure processes
  • Manage projects to completion within schedule and contract specifications
  • Oversee resource planning, team management, and budget control
  • Ensure compliance with quality standards, SOPs, and local regulations
  • Provide guidance to 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 authorization application 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

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