Senior Regulatory Affairs Consultant

We are currently looking for a Senior Regulatory Affairs Consultant!. As a Senior Consultant 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 Senior Consultant 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 provide guidance to project team members on technical/process issues. In this role you will have solid EU regulatory experience, e.g., MAA preparation and submission.  

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

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

• CRO experience

• Experience in MAA preparation and submissions

• Project management knowledge and experience

• Excellent interpersonal and intercultural communication skills, both written and verbal

• Fluent in English