Regulatory Affairs Director

1 week ago

Toronto, Ontario, Canada Parexel Full time

Transforming Regulatory Excellence

At Parexel, we're seeking a seasoned Director, Regulatory Affairs to spearhead our regulatory initiatives. As a key member of our team, you'll leverage your expertise to drive strategic, technical, and regulatory advice for our clients.

Your Key Responsibilities:

  • Foster a culture of growth and development among your team members.
  • Utilize your extensive regulatory experience to provide invaluable guidance on product applications in the US and Canada.
  • Collaborate with regulatory agencies, such as the FDA, to ensure compliance with guidelines and requirements.
  • Interact with stakeholders, including the writing team, subject matter experts, project leadership, and the Sponsor, to deliver high-quality results.
  • Develop and implement efficient workflows and timelines to drive project success.
  • Provide regulatory writing expertise to produce high-quality documentation for submissions.
  • Ensure seamless project delivery by coordinating with the writing team, subject matter experts, project leadership, and Sponsor.
  • Demonstrate exceptional project management skills to meet deadlines and deliver high-quality results.
  • Facilitate effective communication and coordination among stakeholders to achieve project goals.
  • Collaborate with cross-functional teams to align regulatory strategy with overall product development objectives.
  • Implement risk mitigation strategies and address potential challenges in project execution and staff allocation.
  • Foster staff development plans and coordinate with project staffing for optimal utilization and skill expansion.
  • Participate in project scoping calls, proposal preparation, and account planning for key clients.
  • Prospect and leverage new business opportunities in collaboration with Account Management.
  • Communicate organizational vision and values to staff and promote 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.

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