Senior Regulatory Advisor
Offre en anglaisNelvik 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, stabi…
- Télétravail
- ["Toronto, Ontario, Canada"]
- Publié 13 juill. 2026
- Postuler avant le 9 janv. 2027
- 1 poste
Résumé du poste
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. [email protected]
Ce que vous ferez
The Senior Regulatory Advisor will provide expertise in biologics and vaccine pathway assessments to support internal investment decisions. This role focuses on a contemplated vaccine platform for export and technology-transfer initiatives.
Exigences
Candidates should have direct experience with Health Canada biologics and vaccine pathways, as well as various regulatory strategies. Relevant backgrounds include roles in Health Canada, vaccine manufacturing, and regulatory consulting.
Autres compétences pertinentes
Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.
- Health Canada Biologics
- Vaccine Pathways
- BRDD Engagement
- NDS Pathway Strategy
- CTA Pathway Strategy
- CMC Strategy
- GMP
- Lot Release
- Stability
- Analytical Validation
- Batch Consistency
- Clinical Immunogenicity
- Safety Bridging
- Export Regulatory Questions
- Technology Transfer Diligence
Renseignements supplémentaires
- Expérience minimale
- 10+ ans
- Postuler avant le
- 9 janv. 2027