Regulatory Affairs Consultant (Project Lead, CTA)
Czech Republic, Remote Additional Locations: Bucharest, Bucureşti, Romania; Budapest, Budapest, Hungary; Madrid, Madrid, Spain; Milan, Milano, Italy; Prague, Czechia; Uxbridge, Middlesex, United Kingdom; Vilnius, Lithuania; Warsaw, Poland; Zagreb, Croatia Job ID R0000011237 Category Regulatory / Consulting Date Posted 07/28/2023Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
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
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