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Regulatory Affairs Specialist

2 months ago


Montreal, Quebec, Canada Quantum Full time
Senior Regulatory Affairs Specialist

At Quantum, we're seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulations across various product categories, from concept to post-market phases.

Key Responsibilities:
  • Take ownership of regulatory oversight, ensuring seamless collaboration with cross-functional teams.
  • Drive decision-making, navigate ambiguity, and solve regulatory challenges efficiently.
  • Manage regulatory aspects for diverse product categories, including drugs, medical devices, and cosmetics.
  • Oversee facility registrations for various product types.
  • Stay updated on regulatory requirements and provide strategic insights.
  • Effectively communicate regulatory guidance to internal and external stakeholders.
Requirements:
  • Bachelor's degree in Regulatory Affairs, Life Sciences, or related fields.
  • 5+ years of regulatory affairs experience in pharmaceutical, OTC, or consumer goods industries.
  • Profound understanding of Canadian regulations for diverse product categories.
  • Strong problem-solving skills and ability to thrive in a dynamic environment.
  • Bilingualism to understand the documentation for Health Canada and to communicate with the teams in the US and Ontario.
Preferred Skills:
  • Ability to work independently and collaboratively in a remote environment.
  • Familiarity with virtual collaboration tools.
What We Value:
  • Problem-solving mindset.
  • Strong decision-making abilities.
  • Autonomy and accountability in work.
  • Adaptability to ambiguity.
  • A desire for impactful contributions and a strong voice within the organization.