Senior Regulatory Advisor - Vaccines​/Biologics

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.