Regulatory Affairs CMC Consultant (Biologics & Vaccines)

Job title: Regulatory Affairs CMC Consultant (Biologics & Vaccines)Location: Remote (EU / UK)Contract Duration: 6+ MonthsHours: Up to 150 hours per month Company Overview: Apsida Life Science is partnering with a leading global clinical research organization that provides end-to-end clinical development and regulatory consulting services to pharmaceutical, biotechnology, and medical device companies. With a strong global presence, the organization supports clients across the product lifecycle, delivering expertise in clinical research, regulatory affairs, pharmacovigilance, and market access to help bring innovative therapies to patients worldwide. Key Responsibilities: Lead and support the development of CMC content for global regulatory submissions.Author and review CTD Modules 2 and 3, with Module 3 experience being mandatory.Prepare and contribute to CMC sections of regulatory submissions, including INDs, IMPDs, BLAs, NDAs, MAAs, clinical amendments, and post-approval supplements/variations.Incorporate regulatory strategy into submission documentation and ensure consistency across submission components.Review process development and manufacturing raw data and translate technical information into high-quality regulatory documentation.Support preparation and authoring of Pre-IND filings.Provide CMC regulatory input throughout pharmaceutical development and lifecycle management.Review documentation for compliance with applicable regulations, ICH guidelines, and internal standards.Support regulatory change management activities and assess regulatory implications of product and manufacturing changes.Work collaboratively with regulatory, CMC, manufacturing, process development, and cross-functional project teams.Manage assigned deliverables, timelines, and priorities across projects.Maintain appropriate documentation and workflows within Veeva Vault. Required Experience & Qualifications: Strong experience in CMC regulatory affairs / technical CMC within biological and vaccine products.Demonstrated experience supporting regulatory submissions in the US and EU.Mandatory hands-on CMC authoring experience with CTD Module 3 and Module 2.Experience preparing CMC sections for: INDs, IMPDs, BLAs, NDAs, MAAs, Clinical amendments, and Post-approval supplements and variations.Experience with Veeva Vault.Experience reviewing process development and manufacturing data/raw data.Experience preparing or contributing to Pre-IND submissions/filings.Thorough understanding of the drug development process across pharmaceutical development phases.Strong knowledge of global regulatory requirements and ICH guidelines relating to pharmaceutical development and lifecycle management.Understanding of change management processes and associated regulatory requirements.Strong project management and organizational skills. If you are interested in learning more, please reach out to KG Mphahlele at Apsida Life Science: kgmphahlele@apsida.com+44 744 134 1041 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.