Regulatory Affairs Associate (Contract)
Core
Support oncology clinicians and improve patient care by preparing regulatory submissions for GSK's vaccines and specialty medicines portfolio in Canada.
Role type
Regulatory Affairs Associate (Contract)
Builds
Regulatory submissions (NDSs, SNDSs, CTAs, NCs) for Health Canada
Domain
Biopharma / Oncology / Regulatory Affairs
Required skills
Knowledge of Canadian Food and Drug Regulations, understanding of drug development and commercialization, experience with Veeva Vault, ability to interpret regulations and guidelines
Preferred skills
Graduate degree in Regulatory Affairs
Technologies
Veeva Vault, Microsoft Office Suite
Responsibilities
Assist in preparation of regulatory submissions, ensure compliance with Health Canada and GSK guidelines, communicate with global/local teams, resolve basic regulatory questions, build relationships with Health Canada
Seniority
Junior, hands-on IC