Find your next opportunity

Why it matched your search

• Title matches

Job summary

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…

Job details

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. Interested candidates may apply or contact Nelvik Pharma Inc. info@nelvikpharma.com

What you’ll do

The Senior Regulatory Advisor will support a focused biologics/vaccine pathway assessment for Nelvik Pharma Inc. This role is a short-term advisory mandate aimed at aiding internal investment decision-making related to a contemplated vaccine platform.

Requirements

Candidates should have direct experience with various regulatory pathways, particularly in biologics and vaccines. Relevant backgrounds may include roles at Health Canada, vaccine manufacturers, or regulatory consulting firms.

Listed skills

• Validation · Preferred
• Analytical · Preferred
• assessment · Preferred
• Organization · Preferred
• Attention to detail · Preferred
• Health · Preferred
• safety · Preferred
• Decision Making · Preferred
• batch · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Health Canada Biologics
• Vaccine Pathways
• BRDD Engagement
• LATAM Regulatory Authorities
• 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