Senior Regulatory Advisor
About the role
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
Relevant backgrounds may include Health Canada, vaccine manufacturers, biologics-focused regulatory consulting, CDMOs, CROs, or senior CMC/regulatory strategy roles.
Interested candidates may apply or contact Nelvik Pharma Inc. info@nelvikpharma.com