Regulatory Affairs Manager

Apsida Life Science is partnering with a global CRO company to present the following role:

Role Overview

• Title- CTA Regulatory Affairs Consultant
• Contract- 6-12 months
• Remote

Seeking a Clinical Trial Regulatory Affairs SME to support EU/ROW CTA submissions and UK regulatory operations. Ideally, one consultant will cover both areas, although separate SMEs may be considered.

Key Responsibilities

EU & ROW CTA

• Manage regulatory assignment launch and study Kick-Off Meetings.
• Prepare and coordinate Submission Content Plans (SCPs) based on GRSP requirements.
• Create, update and coordinate approval of CITRIS packages.
• Coordinate final submission packages with local teams.
• Maintain and update CTIS records and approval documentation.
• Manage regulatory authority RFIs across EU and ROW.
• Prepare UK submission cover letters and align with content plans.
• Encode and maintain submissions through the IRAS portal.
• Update IRAS forms for amendments.
• Archive submission packages, acknowledgements and approval letters.
• Maintain required regulatory records and system updates.

Requirements

• Strong Clinical Trial Regulatory Affairs / Regulatory Operations experience.
• Hands-on EU CTA, CTIS and CITRIS experience.
• UK IRAS and clinical trial regulatory experience.
• Experience with amendments, RFIs and submission lifecycle management.
• Strong stakeholder coordination skills across global, central and local teams.
• Pharmaceutical, biotech or CRO experience preferred.
• Veeva Vault/RIM experience is advantageous.

If you are interested in learning more, please reach out to Mufaro Mpofu at Apsida Life Science:

[Confidential Information]

www.apsida.co.uk.

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process