Director of Regulatory Compliance

1 week ago


Toronto, Ontario, Canada Parexel Full time

Unlock Your Potential as a Regulatory Affairs Leader

About the Role

We are seeking an experienced Regulatory Affairs Director to join our team at Parexel. As a key member of our organization, you will play a critical role in leading and mentoring a team of high-performing Regulatory Affairs professionals.

Key Responsibilities

  • Foster a culture of excellence and professionalism within the Regulatory Affairs team
  • Provide strategic, technical, and regulatory advice to clients on various innovative product applications
  • Manage client relationships and ensure high-quality deliverables
  • Develop and implement regulatory submission strategies
  • Collaborate with cross-functional teams to ensure alignment of regulatory strategy with overall product development goals
  • Implement strategies to mitigate risks and address potential challenges in project execution and staff allocation
  • Facilitate staff development plans and coordinates with project staffing for appropriate utilization and skill expansion
  • Participate in project scoping calls, proposal preparation, and account planning for key clients
  • Actively prospect and leverages new business opportunities in collaboration with Account Management

Requirements

  • Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree (MSc, PhD) Preferred
  • 10-15 years related Regulatory Affairs experience in the life sciences or consulting industries. Previous CRO or Consulting experience highly preferred
  • 8+ years of experience in people management and leadership experience within the clinical and/or nonclinical regulatory functions

What We Offer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status.



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