Regulatory Affairs Consultant (Project Lead, CTA)

We are currently looking for a Regulatory Affairs Consultant (Project Lead). In this role, you will have a comprehensive understanding of the organization’s consulting models and methodologies and develop specialist knowledge of a particular subject matter or market. A Regulatory Affairs Consultant (Projet Lead) provides a broad range of consulting services and works within project guidelines to identify, refine, and address client issues and to achieve project objectives. You will bring solid EU regulatory experience in clinical trial applications to the role and be able to provide guidance to project team members on technical/process issues. This is a sub-leadership role.

This role can be located in various European countries, home or office based.

Job Responsibilities:

• Works within a team environment or individually based on the project needs

• As a Project Leader, provides overall project leadership

• Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action

• Provides guidance to project team members, and acts as a mentor to junior staff

• Demonstrates the use of the organization’s consulting models and methodologies and uses experience to suggest possible developments/improvements

• Acts as a trusted advisor to clients and/or project team on technical and/or process issues

• Supports development of business solutions addressing specific client needs using best practices and knowledge of the client’s business and key industry drivers

Skills and Experience required for the role:

• University Degree in a Scientific or Technical Discipline, Advanced Degree Preferred

• Around 5 years of Regulatory Affairs experience in an industry-related environment

• Experience in CTA; EU-CTR knowledge

• Project management knowledge and experience

• Experience working on client facing projects - highly desirable

• Excellent interpersonal and intercultural communication skills

• Good consulting skills

• Fluent in English written and verbal