Reg affairs

I'm currently looking for a CMC Regulatory Affairs Specialist with strong experience in late-stage development, EU regulatory submissions, and vaccines/biologics products, with a particular focus on tuberculosis (TB) vaccines. Candidates with broader public health vaccine experience in biologics environments will also be considered, but vaccine experience is a must.

Location: Remote with occasional travel to Spain, Madrid
Contract Length: 6 months (likely extension to 12 months)
Start Date: Early to mid-September
Requirements: Must have the right to work in the EU

Key Experience Required:

• CMC Regulatory Affairs expertise
• Late-stage clinical development and registration activities
• Strong knowledge of EU regulatory requirements
• Experience supporting tuberculosis vaccines or other public health vaccines
• Experience within biologics/vaccine development environments
• Preparation, submission, and lifecycle management of regulatory dossiers
• Prepare, compile and submit global CMC regulatory dossiers, variations, supplements, renewals and lifecycle management submissions.
• Support Health Authority interactions and responses to regulatory queries, deficiencies and information requests.
• Ensure compliance with FDA, EMA, MHRA, ICH and other applicable global regulatory requirements.
• Review change controls, deviations and CAPAs for regulatory impact and submission requirements.
• Provide regulatory guidance for technology transfers, site transfers, process validation and commercial manufacturing changes.
• Support regulatory activities for INDs, IMPDs, CTAs, BLAs, NDAs, MAAs and post-approval submissions.
• Monitor evolving CMC regulatory requirements and communicate impacts to internal stakeholders.
• Contribute to inspection readiness activities and support regulatory audits and inspections.
• Collaborate with external partners, CMOs/CDMOs and global regulatory teams to ensure timely submissions and approvals.
• Maintain regulatory documentation, submission trackers and product registration databases.
• Support product development programs from early clinical phases through commercialization.

This is a highly specialised requirement, and we are specifically looking for professionals who have worked on vaccine-focused regulatory programmes, ideally in late-stage development through registration.