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:
mufaro.mpofu@apsida.com
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

Work arrangement
No