Global Regulatory Affairs - CMC Talent Community

Key Accountabilities:
- 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.
- Ensure Module 3 documentation is planned, tracked, and clearly written using regulatory domain systems (Veeva) and processes.
- Stay current and interpret evolving CMC regulatory requirements and guidelines (e.g., ICH, US FDA CFRs, EMA directives/annexes) and ensure CMC documentation/data are compliant.
- Collaborate with Quality Assurance, CMC/Manufacturing, and preclinical teams to plan and author CMC regulatory scope and content.
- 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.
- Experience with a 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.
- Good analytical and problem-solving skills to assess/mitigate regulatory risks.
- Ability to collaborate and build relationships across functions and geographies.
- Skilled at summarizing manufacturing and method development reports/data into Module 3 subsections.

Application Instructions:
- Submit your information to be connected for future/available Regulatory Affairs - CMC opportunities.