Regulatory Affairs Manager (Hepatology)
Core
Lead regulatory strategies and submissions for specialty medicines and vaccines to Health Canada, ensuring compliance and optimal labeling to support patient care.
Role type
Senior Regulatory Affairs Manager
Builds
Regulatory submissions (NDSs, SNDSs, CTAs, NCs) and approved product labels for GSK's specialty portfolio
Domain
Life Sciences / Pharmaceutical Regulatory Affairs (Canada)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Canadian regulatory affairs expertise, drug lifecycle management, Health Canada compliance, strategic regulatory planning, project management, risk management, scientific background (life sciences)
Preferred skills
Graduate degree in Regulatory Affairs, oncology therapeutic area experience
Technologies
Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
Responsibilities
Develop regulatory strategies for rapid approvals, prepare and file regulatory submissions, ensure compliance with Health Canada guidelines, build relationships with Health Canada contacts, mentor junior staff, interpret Canadian regulations
Seniority
Senior, hands-on IC with mentorship duties
