Telix Pharmaceuticals Limited logo
Telix Pharmaceuticals Limited

Developing theranostics (nuclear medicine) for prostate, kidney, glioblastoma, haematologic cancers and rare diseases.

Senior Manager, Global Regulatory Strategy

ComplianceComplianceFull TimeRemoteSeniorTeam 501-1,000Since 2015H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

10 days ago

Salary

0

Seniority

Senior

Bachelor Degree8 yrs expEnglish

Job Description

Senior Manager, Global Regulatory Strategy

Telix Pharmaceuticals Limited

• Support the development and execution of regulatory strategies for assigned portfolio assets, ensuring alignment with program objectives and global regulatory requirements • Contribute to regulatory planning for new product development, global submissions, and lifecycle management activities across pipeline and commercial assets • Partner cross-functionally to help align regulatory strategies with clinical, CMC, and commercial plans • Maintain awareness of global regulatory frameworks (e.g., FDA, EMA, TGA, PMDA, CDE) and apply them to program-level strategy and execution • Identify regulatory risks and support development of mitigation plans in collaboration with senior regulatory leadership • Lead the preparation for Health Authority interactions and submissions, including preparation of briefing documents, dossiers and other documentation in alignment with regulatory requirements • Manage responses to Health Authority queries and support regulatory milestone deliverables • Ensure documentation and communications are complete, accurate, and aligned with agreed regulatory strategies • Serve as the regulatory lead on assigned R&D project teams and partner cross-functionally with Clinical, Quality, CMC, Commercial, non-clinical and regulatory functions • Provide input and recommendations on regulatory risks, opportunities, and implications across the global portfolio

Job Requirements

  • Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Regulatory Affairs, or related scientific field required
  • 8+ years of experience within pharmaceuticals, biotech, or life sciences
  • 5+ years of experience in Regulatory Affairs
  • Strong background in regulatory strategy for oncology or radiopharmaceutical products is highly desirable
  • Proven experience with global regulatory frameworks (e.g., FDA, EMA, TGA, PMDA, CDE)
  • Prior experience contributing to health authority interactions (briefing support, responses, documentation)
  • Experience working on cross-functional teams (Clinical, CMC, Quality, etc.)
  • Solid understanding of drug development process and regulatory requirements across development and commercialization
  • Ability to translate regulatory guidance into program-level actions
  • Strong project management and organizational skills; able to manage multiple priorities
  • Effective cross-functional collaboration and communication skills
  • Ability to identify risks and escalate appropriately, with sound judgment.

Benefits

  • Competitive salaries
  • Annual performance-based bonuses
  • Equity-based incentive program
  • Generous vacation
  • Paid wellness days
  • Support for learning and development

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