Global Regulatory Affairs - CMC Talent Community

Responsibilities:
- Plan, prepare, and revise eCTD Module 2.3 & Module 3 documents for INDs, IMPDQs, NDAs, BLAs, MAAs, CTAs, post-approval supplements, and variation submissions; ensure accuracy and completeness.
- Ensure Module 3 documentation is planned, tracked, and clearly written using regulatory domain systems (Veeva) and established processes.
- Stay current on and interpret evolving CMC regulatory requirements and guidelines (ICH, US FDA CFRs, EMA directives/annexes) and ensure CMC compliance.
- Collaborate with internal stakeholders (Quality Assurance, CMC/Manufacturing, preclinical) 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.

Qualifications / Experience:
- Undergraduate degree required; advanced degree (M.Sc., Ph.D.) in Biological Sciences, Engineering, or related field preferred.
- Strong CMC experience 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/problem-solving skills to assess and mitigate regulatory risks.
- Ability to work collaboratively across functions and geographies.
- Skilled at summarizing pharmaceutical manufacturing/method development reports and data into Module 3 subsections.

Application Instructions:
- Submit your information to be considered for future openings.