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Regulatory Affairs Director

2 months ago

Toronto, Ontario, Canada EVERSANA Full time
Job Summary

We are seeking a highly experienced and skilled VP, Regulatory to join our team at EVERSANA. As a key member of our leadership team, you will be responsible for driving the strategic and operational aspects of our regulatory affairs function.

Key Responsibilities
  • Develop and implement regulatory strategies to support business development activities and client deliverables.
  • Manage client relationships and ensure timely and effective delivery of regulatory submissions.
  • Oversee the development and submission of Clinical Trial applications, New Drug Submissions, and Supplemental New Drug Submissions to Health Canada.
  • Collaborate with internal departments to deliver on shared projects and ensure effective communication within the team.
  • Develop and implement processes to ensure compliance with regulatory requirements and industry standards.
Requirements
  • Master's degree in a relevant field (e.g. law, science, business).
  • 20+ years of experience in pharmaceutical regulatory affairs in Canada, with a strong background in leadership and management.
  • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
  • Strong analytical and problem-solving skills, with the ability to think strategically and make informed decisions.
  • Proficiency in computer literacy, including eCTD and PRCI publishing.
Preferred Qualifications
  • MSC, MBA, or MBiotec degree.
  • 20+ years of experience in the Canadian pharmaceutical industry, with a strong background in leadership roles.
What We Offer
  • Competitive wages and benefits package.
  • Opportunities for professional growth and development.
  • A dynamic and collaborative work environment.
  • Flexible work arrangements, including remote work options.