Regulatory Associate (CTIS)

Regulatory Associate (CTIS) - Fully remote

I am currently partnered with an exciting global CRO who is seeking a dedicated and detail-oriented Regulatory Associate (entry level) with expertise in the EU Clinical Trials. This role is pivotal in ensuring the compliance and efficiency of regulatory submissions within the EU. The ideal candidate will have a sound knowledge in clinical research or regulatory affairs, excellent communication skills, and the ability to work both independently and as part of a team.

This position is a great opportuntiy to get into the Regulatory industry whether you've just graduated or currently working in the clinical space.

Key Responsibilities

• Support the Regulatory Specialist in the preparation and submission of regulatory dossiers to EU health authorities and Ethics Committees under the Clinical Trial Regulation (CTR) and CTIS.
• Collaborate with the Regulatory Affairs Specialist to prepare and submit responses to regulatory queries in a timely and accurate manner.
• Manage the digital filing of study-related documentation and correspondence, ensuring all records are up-to-date and easily accessible.
• Perform document redactions on behalf of the sponsor to ensure compliance with confidentiality requirements.
• Work effectively within a team environment, contributing to departmental meetings and relevant discussions.
• Maintain and demonstrate a working knowledge of EU submissions under the Clinical Trial Directive (CTD) and the Clinical Trial Regulation (CTR).

Qualifications

• At least 1 year of experience in clinical research regulatory affairs. Also open to candidates who have just comleted their bachelors or masters.
• Excellent communication skills in English.
• Strong organizational skills with keen attention to detail.
• Ability to work independently and as part of a team.
• Demonstrated experience with EU CTIS submissions and regulatory processes (preferred)

Reporting Structure

• Reports To: Regulatory Affairs Specialist
• Direct Reports: None

Additional Information

• This position offers the flexibility of full remote work.
• The candidate must be capable of attending virtual meetings and collaborating with a global team.

Please note that we can't provide sponsorsip at this time.

Apply today or drop me an email rbanton@barringtonjames.com