Regulatory Affairs Director

2 months 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 be responsible for leading and mentoring a team of high-performing Regulatory Affairs professionals, providing strategic, technical, and regulatory advice to clients, and managing client relationships.

Key Responsibilities

  • Foster a culture of professional growth and development within your team
  • Utilize your extensive Regulatory and product development clinical and non-clinical strategy experience to drive business success
  • Provide expertise in interactions with regulatory agencies and regulatory guidelines and requirements
  • Interact with various stakeholders to ensure high-quality deliverables
  • Assist your team in the development of regulatory submission strategies
  • Implement efficient workflows and timelines
  • Provide support to your team in regulatory writing and documentation
  • Ensure high-quality deliverables through effective coordination and communication
  • Demonstrate strong project management skills to ensure on-time and high-quality project delivery
  • Facilitate effective coordination and communication between stakeholders
  • 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
  • Facilitate staff development plans and coordinates with project staffing
  • Participate in project scoping calls, proposal preparation, and account planning
  • Actively prospect and leverage new business opportunities
  • Communicate organizational vision and values to staff and promotes effective information flow

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

Parexel is an Equal Opportunity Employer

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