Regulatory Affairs Specialist

1 week ago


Montreal, Quebec, Canada Quantum Full time
Job Title: Senior Regulatory Affairs Specialist - Medical Writing

Job Type: 12-month contract (maternity leave replacement)

Location: 100% Remote (must be located at maximum 2 hours from the Montreal office)

About the Role:

We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Quantum. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulations across various product categories, from ideation to approval and post-market phases.

Key Responsibilities:

  • Take ownership of regulatory oversight from concept to post-market phases
  • Collaborate across R&D, quality, manufacturing, marketing, and sales teams to ensure regulatory compliance
  • 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
  • Ability to work independently and collaboratively in a remote environment
  • Familiarity with virtual collaboration tools

What We Offer:

At Quantum, we offer a dynamic and supportive work environment that fosters growth and development. As a Senior Regulatory Affairs Specialist, you will have the opportunity to work on a wide range of projects, develop your skills, and contribute to the success of our team.



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