Senior Regulatory Advisor

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

• 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

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