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Talk to Melissa DeSouza, the specialist consultant managing this candidate, located in Toronto

Contact consultant
ttelephone:(416) 367 HAYS (4297)
ffax:(416) 203 1923
Suite 600, 6 Adelaide Street East, Toronto, Ontario, Canada, ON M5C 1H6

Regulatory Affairs Sr. Associate

Toronto Area

Job type

• 2.5 years brand pharmaceutical regulatory experience
• Led the preparation, submission, successful approval and launch of a high profile oncology priority review New Drug Submission
• Responsible for Lifecycle management of a portfolio of products (S/NDS, Notifiable Changes, CTAs, and label review and changes)
• Has covered different therapeutic areas, drug and medical devices (oncology, women’s health, hematology)
• Demonstrated determination, research and communication skills shown in achieving agreement from Health Canada to make a product labeling change to overcome a long-standing marketing challenge. If communication with Health Canada was unsuccessful, other marketed products could have been negatively impacted.
• Effective cross functional collaboration and communication with both internal (i.e. Medical, Marketing, MA, Legal, QA) and external (i.e. Health Canada/FDA) stakeholders
• B.Sc in Life Sciences and Postgraduate certificate in Regulatory Affairs