Sandra’s career in Regulatory Affairs started in 2004, bringing her to 16 years of hands on experience working with the FDA, Health Canada, the EMA and other jurisdictions. 

Sandra trained specifically to be a Regulatory Affairs Specialist with a diploma from Seneca College in Pharmaceutical Regulatory Affairs and Quality Operations as well as a Bachelor of Science degree from the University of Winnipeg.

Sandra’s depth and range of experience has involved multiple INDs, CTAs, NDAs, ANDAs, 510k’s, ITAs, FDA and EMA Orphan Drug Applications, FDA Fast-Track Applications, FDA Rare Pediatric Disease Designations, FDA Special Protocol Assessments, FDA and EMA Pediatric Investigational Plans, FDA and Health Canada Device Classification, Regulatory Milestone Meetings (i.e. FDA and Health Canada pre-IND/CTA Meetings, End of Phase 2 Meetings, pre-NDA/NDS Meetings, EMA Scientific Advice/Protocol Assistance, FDA Q-Submission Meetings) and more . . .

smoothly and effectively leading her clients to many successful development milestones!

Sandra understands that Regulatory Affairs means “living in the grey” as she expertly interprets regulations and manages her team and her client’s projects through what can seem an intimidating and intricate process. 

The complexity and ambiguity of Regulatory Affairs does not daunt Sandra, as she is a master with attention to detail and cool negotiation.   

But most importantly Sandra says with sincerity: “I love my job!” 

And it shows, because she is excellent at it.