Regulatory 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 Brussels, Belgium
Contract Length: 6 months (likely extension to 12 months)
Start Date: Early October
Requirements: Must have the right to work in the EU
Key Experience Required:
- Prepare, compile and submit global CMC regulatory dossiers, variations, supplements, renewals and lifecycle management submissions.
- Develop and execute CMC regulatory strategies to support clinical development, product registrations and post-approval changes.
- Author, review and maintain Module 2 and Module 3 documentation (Quality/CMC sections).
- Coordinate regulatory submissions across manufacturing, process development, analytical development, quality assurance and supply chain teams.
- Assess the regulatory impact of manufacturing, process, analytical, packaging, labelling and supplier changes.
- 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.
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