Manager, Global Regulatory Affairs - CMC
Telix Pharmaceuticals Limited
June 25, 2026
Remote friendly (United States)
United States
Corporate Functions
Manager, GRA - CMC
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: Interpret evolving CMC regulatory requirements and guidelines (ICH, US FDA CFRs, EMA directives/annexes) to ensure CMC documentation and data compliance.
- 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.
- Risk Management: Identify CMC regulatory risks and propose mitigation plans.
Education And Experience
- Undergraduate degree required; M.Sc./Ph.D. in Biological Sciences, Engineering, or related field preferred.
- 7+ years of experience with strong CMC focus in radiopharmaceutical or biopharmaceutical industry.
- Solid understanding of global CMC regulatory requirements (ICH, FDA, EMA, and other health authority regulations).
Required Skills / Capabilities
- Excellent technical writing and verbal communication.
- Strong analytical and problem-solving skills for risk assessment/mitigation.
- Collaborative interpersonal skills across functions and geographies.
- Ability to summarize manufacturing and method development reports/data into Module 3 sub-sections.
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: Interpret evolving CMC regulatory requirements and guidelines (ICH, US FDA CFRs, EMA directives/annexes) to ensure CMC documentation and data compliance.
- 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.
- Risk Management: Identify CMC regulatory risks and propose mitigation plans.
Education And Experience
- Undergraduate degree required; M.Sc./Ph.D. in Biological Sciences, Engineering, or related field preferred.
- 7+ years of experience with strong CMC focus in radiopharmaceutical or biopharmaceutical industry.
- Solid understanding of global CMC regulatory requirements (ICH, FDA, EMA, and other health authority regulations).
Required Skills / Capabilities
- Excellent technical writing and verbal communication.
- Strong analytical and problem-solving skills for risk assessment/mitigation.
- Collaborative interpersonal skills across functions and geographies.
- Ability to summarize manufacturing and method development reports/data into Module 3 sub-sections.