Regulatory Affairs Director

3 weeks ago

Québec, Quebec, Canada Parexel Full time
Lead Regulatory Affairs Expert

Parexel is seeking a seasoned Regulatory Affairs Director to join our team. 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 professional growth and development for direct reports
  • Utilize extensive Regulatory and product development clinical and non-clinical strategy experience for all phases applications in the US and Canada
  • Provide expertise in interactions with regulatory agencies and regulatory guidelines and requirements
  • Interact with various stakeholders, including writing teams, subject matter experts, project leadership, and sponsors
  • Assist the team in developing regulatory submission strategies
  • Utilize expertise to create efficient workflows and timelines
  • Provide support to the team and utilize regulatory writing expertise to produce high-quality documentation for regulatory submissions
  • Ensure high-quality deliverables by coordinating with writing teams, subject matter experts, project leadership, and sponsors
  • Demonstrate strong project management skills to ensure on-time and high-quality project delivery
  • Facilitate effective coordination and communication between stakeholders to achieve project goals
  • 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, resourcing needs
  • 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 leverage 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

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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