Regulatory Affairs Manager (CMC and/or Oncology)
Core
Lead regulatory strategies and submissions for oncology or CMC products to Health Canada, ensuring compliance and optimal labeling.
Role type
Senior Regulatory Affairs Manager (Oncology/CMC)
Builds
Regulatory submissions (NDSs, SNDSs, CTAs, NCs) for new and existing products
Domain
Biopharmaceuticals / Oncology / CMC / Canadian Regulatory Affairs
Required skills
Canadian regulatory strategy, submission preparation, Health Canada liaison, drug development lifecycle knowledge, project management, risk management, regulatory compliance
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 guidelines, build trust with Health Canada contacts, mentor junior staff, interpret Canadian regulations
Seniority
Senior, hands-on IC with mentorship