Director – Global Regulatory Affairs

See Yourself at Telix

The Director of Global Regulatory Affairs is a senior leadership position responsible for developing and executing global regulatory strategies for Telix’s Precision Medicine (radiopharmaceutical diagnostics) drug products. The role involves collaborating with cross-functional teams, managing regulatory submissions, and ensuring compliance with international regulatory requirements throughout the product lifecycle. This position requires deep expertise in regulatory affairs, strategic leadership, and the ability to navigate complex global regulatory landscapes.

Key Accountabilities:

• Regulatory Strategy Development
  • Lead the development and implementation of global regulatory strategies for small molecule products, from early development through commercialization.
  • Identify and mitigate regulatory risks, ensuring alignment with business objectives and timelines.
  • Provide strategic regulatory guidance to cross-functional teams, including R&D, clinical, manufacturing, and commercial teams.
• Regulatory Submissions and Approvals
  • Oversee the preparation, submission, and management of regulatory filings, including INDs, NDAs, BLAs, MAAs, and other global regulatory submissions.
  • Liaise with global health authorities, including the FDA, EMA, and other regulatory bodies, to facilitate product approvals.
  • Ensure timely responses to regulatory inquiries and oversee the negotiation of regulatory pathways.
• Compliance and Regulatory Intelligence
  • Ensure that all regulatory activities are conducted in compliance with applicable laws, regulations, and guidelines.
  • Monitor the global regulatory environment, assess the impact of new regulations, and communicate changes to relevant stakeholders.
  • Develop and implement regulatory policies, procedures, and best practices.
• Leadership and Team Management
  • Lead, mentor, and develop a high-performing global regulatory affairs team.
  • Foster a collaborative and innovative team culture, promoting professional growth and continuous learning.
  • Allocate resources effectively to meet project timelines and regulatory goals.
• Cross-functional Collaboration
  • Collaborate with internal and external stakeholders, including clinical, manufacturing, legal, and commercial teams, to ensure regulatory alignment.
  • Represent regulatory affairs in senior management meetings and decision-making processes.
  • Build and maintain relationships with key regulatory agencies and external partners.
• Regulatory Diligence and Support for Business Development
  • Provide regulatory due diligence and support for business development activities, including mergers and acquisitions, licensing, and partnership opportunities.
  • Assess regulatory risks and opportunities for potential new projects or acquisitions.

Education and Experience:

• Bachelor’s degree required; Advanced degree in life sciences, pharmacy, chemistry, or a related field (Ph.D., Pharm.D., or M.S.) preferred.
• 10+ years of experience in regulatory affairs, with a strong focus on regulatory strategy for global drug development.
• Proven track record of successful global regulatory submissions and approvals.
• In-depth knowledge of global regulatory requirements and guidelines for both small molecule and biologics drug development.
• Experience in radiopharmaceuticals and/or diagnostics drug products preferred.
• Experience in leading and managing regulatory teams, with a demonstrated ability to mentor and develop staff.
• Strong analytical, strategic thinking, and problem-solving skills.
• Excellent communication and negotiation skills, with the ability to influence and build consensus across diverse teams.
• Ability to work effectively in a fast-paced, dynamic environment with changing priorities.
• Experience in regulatory interactions with global health authorities, including FDA and EMA.
• Proven ability to manage multiple projects and priorities simultaneously.

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills