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

Johnson & Johnson MedTech

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
This Senior Associate, Regulatory Affairs 18-month Fixed Term Contract is responsible for supporting the regulatory activities to obtain and maintain drug product registration status in compliance with Canadian drug laws and regulations, as well as corporate policies and procedures

Job Summary

  • This Senior Associate, Regulatory Affairs 18-month Fixed Term Contract is responsible for supporting the regulatory activities to obtain and maintain drug product registration status in compliance with Canadian drug laws and regulations, as well as corporate policies and procedures.
  • The role involves developing and implementing regulatory strategic plans, managing submissions to Health Canada, and serving as the primary point of contact for Drug Establishment Licensing activities.
  • Johnson & Johnson provides an inclusive work environment that respects diversity and dignity, and offers accommodation during the recruitment process to ensure full participation.

Matching Summary

This Senior Associate, Regulatory Affairs 18-month Fixed Term Contract is responsible for supporting the regulatory activities to obtain and maintain drug product registration status in compliance with Canadian drug laws and regulations, as well as corporate policies and procedures.

Salary

Base: 107,550.00 - 157,550.00 CAD; Bonus/Equity: Discretionary performance bonus eligible; 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 impact assessment

Nice-to-have

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

Key Requirements

  • Minimum B.Sc. in Biological or related sciences
  • 4 years pharmaceutical or medical device Regulatory Affairs experience
  • Knowledge of Canadian drug laws and Health Canada processes
  • Regulatory Affairs and Quality Operations certification preferred
  • Experience with New Drug Submissions and CMC documentation
  • Ability to interpret clinical data and biostatistics

Work Rights

Not specified

Tailored Resume

Cover Letter