Regulatory Affairs Specialist

18 hours ago


Vancouver, British Columbia, Canada EightSix Network Full time

**Clinical Trial Application Manager Role**

We are seeking a skilled Regulatory Affairs Specialist to join our team in the role of Clinical Trial Application Manager. This position is responsible for managing and submitting initial Clinical Trial Applications (CTAs), amendments, responses, and updates.

The successful candidate will have strong knowledge of Health Canada regulations and requirements, as well as experience working in drug development and clinical research. They will be able to collaborate with cross-functional teams to ensure high-quality regulatory submissions.

This is a renewable contract position that offers the opportunity to work remotely in Quebec or Ontario. The ideal candidate will have excellent organizational and planning skills, as well as strong negotiation, communication, and interpersonal skills.

About the Job

  • Collaborate with internal teams to manage CTA submissions
  • Maintain awareness of new and changing CTA requirements
  • Provide expertise in support of clinical study feasibility and startup activities
  • Oversight of electronic Trial Master File (eTMF) submission activities
  • Support corporate audits and HC inspections

Requirements

  • University degree in Health Sciences
  • Minimum 2 years of experience in Regulatory Affairs
  • Strong knowledge of drug development and clinical research
  • Excellent organizational and planning skills
  • Strong negotiation, communication, and interpersonal skills

About the Salary

The estimated salary for this position is between $60,000 and $80,000 per year, depending on experience and location. We offer a competitive compensation package, including benefits and opportunities for professional growth and development.



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