Telix Pharmaceuticals (AMER)

Telix Pharmaceuticals (AMER)

Associate Director Regulatory Affairs (Operations)

USA- Remote · Director

Sponsorship not specifiedDetected 27 days ago
Project ManagementExcelVendor ManagementFDA RegulatoryLeadershipCommunicationCollaborationAdaptabilityMicrosoft OfficeRegulatory Affairs

About the role

  • Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States.
  • You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.
  • This position is critical to strengthening operational control, reducing risk, and alleviating execution bottlenecks by driving accountability for operational excellence.

Responsibilities

  • Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
  • Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine.

Requirements

  • Bachelor's degree in Life Sciences or a related discipline is required.
  • Minimum of 9 years of relevant experience in Regulatory Affairs or Regulatory Operations within the pharmaceutical or biotechnology industry, including demonstrated leadership experience of at least 2 years.
  • Experience with Regulatory Information Management Systems (RIMS), Electronic Document Management Systems (EDMS), and electronic publishing tools
  • experience with Veeva Vault Regulatory is required.
  • Strong working knowledge of the drug development process and global regulatory frameworks.
  • Experience managing with and/or overseeing external publishing service providers for regulatory submissions is desirable.
  • Advanced proficiency with Microsoft Office Suite (Word, Excel, PowerPoint) and collaboration tools such as Microsoft Teams.
  • Strong Knowledge of global regulatory submission standards and requirements, including FDA, EMA, ICH guidelines, and eCTD submission formats.
  • Expertise in eCTD publishing and lifecycle management
  • Ability to work effectively in a collaborative, fast-paced, mid-size company environment.

Skills

  • Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
  • Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
  • Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
  • Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
  • Telix Pharmaceuticals is an equal opportunity employer.
  • Regulatory Operations Leadership
  • Process & System Management
  • Ensure adherence to global submission standards, including eCTD structure, formatting, and publishing requirements.
  • Team Leadership
  • Oversee vendor relationships and outsourced publishing activities, ensuring performance, quality, and cost-effectiveness.
  • Submission Strategy Support

Compensation

  • We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Benefits

  • Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
  • We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.
  • We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

Company info

  • At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity.
  • You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives.

Equal opportunity

  • equal opportunity employer.
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