Regulatory Affairs Manager (CMC and/or Oncology)
Core
Lead regulatory strategies and submissions for oncology or CMC products to Health Canada, ensuring compliance and optimizing approval times and labeling.
Role type
Senior Regulatory Affairs Manager (Oncology/CMC)
Builds
Regulatory submissions (NDSs, SNDSs, CTAs, NCs) for GSK's oncology and CMC portfolios
Domain
Biopharmaceuticals, Oncology, CMC (Chemistry, Manufacturing, and Controls)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Canadian regulatory affairs expertise, drug development lifecycle knowledge, Health Canada compliance, project management, strategic regulatory planning, issue resolution, mentoring
Preferred skills
Graduate degree in Regulatory Affairs, experience with small molecules/vaccines/biologics
Technologies
Word, Excel, PowerPoint, Outlook
Responsibilities
Develop regulatory strategies for rapid approvals; prepare and file regulatory submissions; ensure compliance with Health Canada and GSK guidelines; build trust with Health Canada contacts; interpret Canadian regulations; mentor junior staff
Seniority
Senior, hands-on IC with mentorship duties