Regulatory Affairs Consultant – CTA

This is a fully remote position, open to applicants in Hungary.

📋 Description

• Collaborate with study teams, taking charge of the necessary regulatory activities, standards, and deliverables related to the development of CTA submissions.

• Complete all required documentation as necessary.

• Lead and participate in pertinent meetings to promote realistic timelines for deliverables, comprehend project strategies, evaluate impacts, and present the status of global submission deliveries.

• Support and spearhead global team initiatives to guarantee high-quality, compliant components and submissions.

• Manage the compilation process for the core package build, contributing to both CTA and authoring documentation.

• Escalate, notify, and resolve issues impacting submission builds or global submission delivery logistics in collaboration with regional and local partners or Health Authorities.

• Operate under the general supervision of a Project Lead and/or Technical Subject Matter Expert (SME).

• Ensure timely delivery of client work in line with business and client quality standards.

• Potentially perform in a client-facing capacity with the support and guidance of line management.

⛳️ Requirements

• A minimum of a Bachelor’s Degree in a Scientific or Technical Discipline.

• Several years of experience in a CRO/Pharma environment.

• Experience with clinical trial submissions to the relevant Regulatory Authorities.

• A client-focused approach to work.

• Exceptional interpersonal and intercultural communication skills, both written and verbal.

• Strong critical thinking and problem-solving abilities.

• Proficiency in English and the local language (both written and spoken).

🏝️ Benefits

• Training and insight into the organization’s foundational consulting models and methodologies.

• An understanding of the services offered by Parexel.

• Support from senior staff to facilitate the completion of more complex tasks.