Global Regulatory Affairs - CMC Talent Community
Telix Pharmaceuticals Limited
August 07, 2026
Remote friendly (United States)
United States
Corporate Functions
Key Accountabilities
- Regulatory Submissions: Plan, prepare/revise eCTD Module 2.3 & Module 3 documents for INDs, IMPDQs, NDAs, BLAs, MAAs, CTAs, post-approval supplements, and variation submissions, ensuring accuracy and completeness.
- Documentation and Systems: Ensure Module 3 documentation is planned, tracked, clearly written, using regulatory domain systems (Veeva) and processes.
- Regulatory Compliance and Intelligence: Stay current and interpret evolving CMC regulatory requirements and guidelines (ICH, US FDA CFRs, EMA Directives and Annexes) and ensure compliance of CMC documentation and data.
- Cross-Functional Collaboration: Collaborate with Quality Assurance, CMC/Manufacturing, and preclinical teams to plan and author CMC regulatory scope and content.
- Change Management: Provide regulatory assessments for manufacturing changes (site transfers, scale-up, process changes); conduct comparability assessments and develop post-approval supplements as needed.
Education and Experience / Qualifications
- Undergraduate degree required; M.Sc. or Ph.D. in Biological Sciences, Engineering, or related field preferred.
- Strong focus on CMC in radiopharmaceutical or biopharmaceutical industry.
- Solid understanding of global CMC regulatory requirements (ICH, FDA, EMA, and other health authority regulations).
- Excellent technical writing and verbal communication skills; ability to communicate complex regulatory issues.
- Good analytical and problem-solving skills to assess/mitigate regulatory risks.
- Ability to collaborate across functions and geographies.
- Skilled at summarizing pharmaceutical manufacturing and method development reports/data into Module 3 sub-sections.
Application Instructions
- Submit your information to be considered for future regulatory affairs (CMC) opportunities.
- Regulatory Submissions: Plan, prepare/revise eCTD Module 2.3 & Module 3 documents for INDs, IMPDQs, NDAs, BLAs, MAAs, CTAs, post-approval supplements, and variation submissions, ensuring accuracy and completeness.
- Documentation and Systems: Ensure Module 3 documentation is planned, tracked, clearly written, using regulatory domain systems (Veeva) and processes.
- Regulatory Compliance and Intelligence: Stay current and interpret evolving CMC regulatory requirements and guidelines (ICH, US FDA CFRs, EMA Directives and Annexes) and ensure compliance of CMC documentation and data.
- Cross-Functional Collaboration: Collaborate with Quality Assurance, CMC/Manufacturing, and preclinical teams to plan and author CMC regulatory scope and content.
- Change Management: Provide regulatory assessments for manufacturing changes (site transfers, scale-up, process changes); conduct comparability assessments and develop post-approval supplements as needed.
Education and Experience / Qualifications
- Undergraduate degree required; M.Sc. or Ph.D. in Biological Sciences, Engineering, or related field preferred.
- Strong focus on CMC in radiopharmaceutical or biopharmaceutical industry.
- Solid understanding of global CMC regulatory requirements (ICH, FDA, EMA, and other health authority regulations).
- Excellent technical writing and verbal communication skills; ability to communicate complex regulatory issues.
- Good analytical and problem-solving skills to assess/mitigate regulatory risks.
- Ability to collaborate across functions and geographies.
- Skilled at summarizing pharmaceutical manufacturing and method development reports/data into Module 3 sub-sections.
Application Instructions
- Submit your information to be considered for future regulatory affairs (CMC) opportunities.