See Yourself at Telix

As the Director, Global Regulatory Affairs Operations, you will play a pivotal role in ensuring regulatory compliance and operational efficiency across our international markets. You will lead a team responsible for coordinating regulatory submissions, managing regulatory documentation, and driving strategic initiatives to streamline regulatory processes.

Key Accountabilities

• Leadership and Team Management
  • Provide strategic direction and leadership to the global regulatory affairs operations team.
  • Foster a culture of collaboration, innovation, and continuous improvement within the department.
  • Develop, train and mentor team members to enhance their regulatory expertise and operational capabilities.
• Regulatory Submission Management
  • Oversee the preparation, submission, and maintenance of regulatory filings for investigational and marketed products across multiple regions.
     Ensure timely completion of regulatory submissions in compliance with global regulatory requirements and company standards.
  • Implement best practices and standardized processes to optimize submission timelines and quality.
• Regulatory Document Management
  • Develop and maintain systems for the organization, tracking, and archiving of regulatory documents and correspondence.
  • Ensure accuracy, completeness, and accessibility of regulatory documentation for internal and external stakeholders.
  • Collaborate with cross-functional teams to establish document management standards and procedures.
• Process Optimization and Compliance
  • Identify opportunities to streamline regulatory processes and improve operational efficiency.
  • Lead initiatives to implement regulatory intelligence tools and technologies to support regulatory activities.
  • Stay abreast of evolving regulatory requirements and industry trends to ensure compliance and mitigate risks.
• Cross-Functional Collaboration
  • Partner with internal stakeholders, including Regulatory Affairs, Clinical Development, Quality Assurance, and Commercial teams, to support product development and commercialization activities.
  • Collaborate with external partners, regulatory agencies, and consultants to resolve regulatory issues and facilitate regulatory interactions.

Education and Experience

• Bachelor’s degree in life sciences, pharmacy, or related field required; advanced degree preferred.
• 8+ years of experience in regulatory affairs operations within the pharmaceutical or biotechnology industry, with at least 3 years in a leadership role.
• Expert knowledge of technical requirements for electronic submissions and data standards.
• Prior experience with a RIM system required; RIM system implementation strongly preferred.
• Proven track record of successful regulatory submissions and approvals in multiple regions (e.g., FDA, EMA, Health Canada, PMDA).
• Strong understanding of global regulatory requirements and guidelines governing drug development and registration.
• Excellent leadership, communication, and interpersonal skills.
• Ability to effectively manage multiple priorities in a fast-paced environment.
• Experience with regulatory document management systems and electronic submission platforms is desirable.
• Ability to travel globally up to 10%