Senior Regulatory Affairs Associate

GALDERMA AUSTRALIA

Toronto, Ontario, Canada
Base: $80,000 - $95,000; bonus: + bonus; benefits:...
7+ years canadian regulatory affairs experience
Health canada regulations knowledge
Plain language labelling expertise
The role involves independently managing the preparation and review of regulatory submissions for Therapeutic Dermatology, Injectable Aesthetics, and Dermatological Skincare products

Job Summary

  • The role involves independently managing the preparation and review of regulatory submissions for Therapeutic Dermatology, Injectable Aesthetics, and Dermatological Skincare products.
  • Candidates must possess extensive knowledge of Health Canada laws regarding prescription drugs, devices, OTC drugs, NHPs, and cosmetics to ensure timely approval.
  • Galderma offers a supportive environment focused on personal growth, diversity, and empowering employees to make a direct impact on consumer and patient outcomes.

Matching Summary

The role involves independently managing the preparation and review of regulatory submissions for Therapeutic Dermatology, Injectable Aesthetics, and Dermatological Skincare products.

Salary

Base: $80,000 - $95,000; Bonus: Plus bonus; Benefits: Not specified

Skills & Requirements

Must-have

  • 7+ years Canadian Regulatory Affairs experience
  • Health Canada regulations knowledge
  • Plain Language Labelling expertise
  • eCTD submission preparation
  • Adverse effect risk assessment

Nice-to-have

  • Mentoring junior RA staff
  • Agility in learning new technologies
  • Cross-functional collaboration skills
  • Positive energy and initiative

Key Requirements

  • Bachelor's degree in science or related field
  • 7+ years of Canadian Regulatory Affairs experience
  • Proficiency with electronic review systems

Work Rights

Not specified

Tailored Resume

Cover Letter