Senior Associate, Regulatory Affairs 18-month Fixed Term Contract (toronto, Ontario)

Johnson & Johnson

Toronto, Ontario, Canada
Base: 107,550.00 - 157,550.00 cad; bonus/equity: d...
Regulatory submissions to health canada
Drug product registration compliance
Clinical and cmc regulatory activities
Johnson & Johnson provides an inclusive work environment where each person is considered as an individual and respects the diversity and dignity of employees

Job Summary

  • Johnson & Johnson provides an inclusive work environment where each person is considered as an individual and respects the diversity and dignity of employees.
  • This Senior Associate role supports regulatory activities to obtain and maintain drug product registration status in compliance with Canadian drug laws and regulations and provides guidance to local and global business partners.
  • The position involves collaboration with global cross-functional teams and includes up to 10% travel, with opportunities to contribute to process improvements and regulatory strategy alignment with business priorities.

Matching Summary

Johnson & Johnson provides an inclusive work environment where each person is considered as an individual and respects the diversity and dignity of employees.

Salary

Base: 107,550.00 - 157,550.00 CAD; Bonus/Equity: discretionary performance bonus; Benefits: Not specified

Skills & Requirements

Must-have

  • Regulatory submissions to Health Canada
  • Drug product registration compliance
  • Clinical and CMC regulatory activities
  • Regulatory strategy development
  • Health Canada interactions
  • Regulatory affairs management

Nice-to-have

  • Cross-functional team collaboration
  • Process improvement initiatives
  • Scientific writing skills
  • Problem solving and analytical skills
  • Regulatory environment monitoring
  • Risk communication management
  • Coaching and communication

Key Requirements

  • Minimum B.Sc. in Biological or related sciences
  • MSc/PhD preferred
  • Minimum 4 years pharmaceutical regulatory experience with B.Sc.
  • Minimum 2 years pharmaceutical regulatory experience with MSc/PhD
  • Knowledge of Canadian drug laws and Health Canada processes
  • Regulatory Affairs and Quality Operations certification preferred

Work Rights

Not specified

Tailored Resume

Cover Letter