Regulatory Affairs Consultant
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Plaats
BruxellesBelgië
België
Contract
Vooltijds, Onbepaalde duurDatum gepubliceerd
2026-05-28Online to:
2026-07-27EUR 20.00 HOUR
Regulatory Affairs Consultant
- Blackfield Associates
- België
- Andere
- 2 dagen geleden
Senior Regulatory Affairs CMC Consultant
Lessines, Belgium (Hybrid)
Contract (Approx. 8 months)
Immediate Start Required
Overview:
We’re seeking a Senior RA CMC Consultant to support a strategic GMP expansion programme within a global biopharmaceutical environment. This is a delivery‑critical role where you will take full ownership of submission content and directly influence regulatory approvals and production readiness.
Key Responsibilities:
- Lead development of CTD Modules 2 & 3 for FDA and AFMPS submissions
- Translate complex CMC and validation data into high‑quality regulatory documentation
- Manage review cycles, stakeholder alignment, and submission readiness
- Deliver multi‑bundle FDA submission packages to strict timelines
What We’re Looking For:
- 5–8+ years’ experience in Regulatory Affairs CMC
- Strong FDA submission experience (essential)
- Expertise in CTD Modules 2 & 3
- Solid understanding of GMP environments, validation & qualification
- Ability to work autonomously with minimal SME input