Nelvik Pharma Inc. is seeking a senior regulatory advisor for a focused biologics/vaccine pathway assessment.
Note: this is a short-term advisory mandate to support internal investment decision‑making.
The mandate relates to a contemplated vaccine platform intended to support export, access, and potential technology‑transfer initiatives.
We are looking to speak with advisors who have direct experience with one or more of the following:
Health Canada biologics/vaccine pathways
BRDD engagement
Experience with LATAM regulatory authorities
NDS / CTA pathway strategy
CMC strategy for biologics or vaccines
GMP, lot release, stability, analytical validation, and batch-consistency expectations
clinical immunogenicity and safety bridging considerations
export-related regulatory questions, including DEL/GMP, CPP, or Section 37 considerations
right-of-reference and technology-transfer diligence
Relevant backgrounds may include Health Canada, vaccine manufacturers, biologics-focused regulatory consulting, CDMOs, CROs, or senior CMC/regulatory strategy roles.