Regulatory Affairs Associate - CTA Experience [Czech Republic]

 

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

This role can be either office based in Prague, or you can be fully home based anywhere in Czech Republic. The office is open planned, and you will be working in an innovative and collaborative environment connecting with colleagues from around the world. .

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This Regulatory Affairs Associate may work on some clinical trials as a LRC (local regulatory contact) for the Czech Republic, Slovakia and Canada and/or as EU RL (regulatory lead) for clinical trial applications submitted according to the EU CTR.

Standard Accountabilities:

Project Execution

• Works within a team environment or individually based on the project needs
• Works within broad project guidelines and facilitates issue and conflict resolutions

Consulting Activities and Relationship Management

• Demonstrates the use of the organization’s consulting models and methodologies and uses experience to suggest possible developments/improvements
• Provides a full range of technical and/or business consulting services within personal area of expertise dealing mainly in areas where policy or precedent is clear
• Completes activities and may delegate activities within project scope and objectives in a timely manner with an understanding of issues which may impact project profitability, quality, and client satisfaction

Parexel related responsibilities

• Meets established metrics as specified in scorecard on an annual basis
• Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management.

• Qualifications :

Education:

• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred

Language skills :

• Must be fluent in Czech and English communication skills in both written and verbal format .

Skills:

• High-level consulting skills
• Critical thinking and problem-solving skills
• Project leadership and management knowledge
• Excellent interpersonal and intercultural communication skills, both written and verbal
• Client-focused approach to work
• Results orientation
• Teamwork and collaboration skills
• Proficiency in local language and extensive working knowledge of the English language
• Networking
• Business analysis
• Self-confidence and control

Knowledge and Experience:

• Strong experience working in a CRO industry-related environment; experience with a regulatory agency (such as FDA, MHRA) is a plus
• Previous experience of managing and submitting marketing authorization dossiers for Czech Republic and Slovakiais essential
• Previous CRO / Pharma experience working in the capacity of a Regulatory Affairs with CTA submission knowledge is essential
• Client-focused approach to work

In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary, bonus and benefits package including days holiday and other leading edge benefits that you would expect with a company of this type.

Apply today to begin your Parexel journey!

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