▪ Canadian Food
and Drugs Act and Regulations
NHP Regulations
Cosmetic Regulations
ICH guidelines
Drug development process ▪ eCTD format for marketing authorization applications
post-market changes
response to a deficiency notice ▪ Good Manufacturing Practices (GxP)
Change control
Internal audits
Corrective and Preventive Actions (CAPA)
SOP writing
Regulatory documentation ▪ Designing label/package mockups
patient information leaflets
and post-approval labeling maintenance ▪ Strong analytical skills with the ability to assess scientific data ▪ Ability to maintain a high level of accuracy and attention to detail
while meeting deadlines for assigned projects ▪ Interpersonal
written
and verbal communication skills ▪ Good computer and project management skills ▪ Maintain Product Information databases ▪ Search Pub Med and other online databases and summarize the literature