Regulatory Affairs Consultant

Apsida Life Science is partnering with a global CRO company to present the following role: We are seeking an experienced Regulatory CMC Consultant / Senior Consultant to provide dedicated regulatory support for a post-approval vaccine product within an Infectious Disease portfolio. This is a hands-on lifecycle management role focused on developing and implementing effective CMC regulatory strategies for post-approval activities across global markets, with particular importance placed on UK market experience. The consultant will work closely with CMC, Quality, Manufacturing, Regulatory Affairs, and cross-functional teams to assess changes, identify regulatory risks, and ensure post-approval submissions are scientifically sound, submission-ready, and aligned with Health Authority expectations. KEY RESPONSIBILITIESDevelop and implement Regulatory CMC strategies for the lifecycle management of post-approval vaccine products.Support post-approval activities including variations, Annual Strain Updates (ASUs), and responses to post-approval commitments.Evaluate CMC change controls and determine their regulatory impact and appropriate submission requirements.Provide regulatory CMC guidance to CMC, Manufacturing, Quality, and other cross-functional stakeholders.Identify, assess, and communicate regulatory risks and potential submission challenges.Review CMC documentation for submission readiness, accuracy, completeness, and compliance with Health Authority requirements.Ensure regulatory submissions and supporting documentation are aligned with applicable UK, EU, and global guidelines.Support preparation and review of regulatory submission documents and CMC content.Contribute to regulatory briefing materials, as required.Provide regulatory input into post-approval manufacturing, process, analytical, and product changes.Work collaboratively with technical SMEs to resolve CMC issues and ensure appropriate supporting data are available.Support Health Authority interactions and responses related to post-approval CMC activities.Manage multiple CMC lifecycle activities and deliverables in line with agreed project timelines.Maintain clear communication of submission status, risks, dependencies, and key regulatory decisions to project stakeholders. REQUIRED EXPERIENCEStrong experience in CMC Regulatory Affairs, preferably within vaccines, biologics, or infectious disease products.Demonstrated experience supporting post-approval lifecycle management of pharmaceutical or biological products.Experience with post-approval variations, Annual Strain Updates (ASUs), and post-approval commitments.Hands-on experience evaluating CMC change controls and determining regulatory impact.Strong understanding of CMC regulatory requirements and Health Authority expectations.Experience reviewing regulatory documentation for submission readiness and compliance.Previous experience supporting the UK market is required.Strong knowledge of UK/EU regulatory requirements and ICH guidelines. 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