Regulatory Affairs Specialist

4 weeks ago

Nova Scotia, Canada Parexel Full time
Regulatory Affairs Consultant

About the Role

Parexel, a leading clinical research organization, is seeking a highly experienced Regulatory Affairs Consultant to join our team in Canada. As a key member of our Regulatory team, you will play a critical role in managing global regulatory strategies and leading a team of local experts.

Key Responsibilities

  • Review critical technical documents, such as clinical trial protocols, reports, and study drug labels, to ensure regulatory compliance and consistency across all materials.
  • Interface with project teams and regulatory authorities on technical matters and support sponsors in developing optimized clinical trial submission strategies.
  • Manage information flow, track project progress, and resolve issues in a collaborative team environment.

Requirements

  • Minimum of six years of experience in the Clinical Trial Regulatory Area, with a proven track record as a global regulatory affairs lead.
  • Advanced English language skills, both written and spoken, and a client-focused approach to work.
  • Results orientation, teamwork, and collaboration skills, as well as consulting abilities and excellent interpersonal and intercultural communication skills.

What We Offer

This opportunity at Parexel offers a chance to work with a highly skilled team in a dynamic and growing field, making a significant impact on the regulatory aspects of clinical trials on a global scale.

Preferred Location

Candidates in the Eastern Time Zone of Canada are highly preferred due to the nature of the Consultant's projects.

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