- Represent Regulatory CMC on cross-functional teams to help progress CARGO's cell-based gene therapy pipeline
- Proactively identify and communicate risks and propose solutions to complex regulatory CMC issues
- Develop comprehensive CMC regulatory filing strategies that anticipate and meet the requirements and expectations of global health authorities for cell-based gene therapies
- Guide and lead teams in seeking scientific advice from health authorities on CMC development aspects
- Interpret global regulations and guidance to identify regulatory opportunities and risks to CARGO's cell-based gene therapy portfolio
- Evaluate technical change proposals and develop effective implementation strategies as appropriate
- Lead technical teams in the development of CMC submissions (IND/IMPD, MAA/BLA) for global markets ensuring compliance, quality, coherence, and timeliness, including creation and maintenance of strategy documents
- Support departmental initiatives, including special projects, budgeting, and authoring departmental documents such as operating procedures, manuals and guides
- Collaborate effectively with technical SMEs to evaluate technical and health authority requirements and prepare CMC sections of the regulatory dossiers
- Minimum of Bachelor's degree in a scientific or engineering discipline
- 10+ years of experience working directly in regulatory CMC or in a relevant technical development discipline, such as process development, analytical development, or quality assurance, including at least 6 years' experience directly in CMC regulatory
- Advanced knowledge of FDA, EMA and ICH guidelines and regulatory requirements
- Experience in developing biologic drugs is essential, with a strong preference for experience leading CMC regulatory strategy for cell-based gene therapies
- Prior experience with the preparation of biologic marketing applications through the review and approval process in major markets is advantageous
- Ability to understand technical aspects of the manufacture, characterization and control of biologic therapies and describe them in regulatory submissions
- Strong planning and organizational skills with a history of prioritizing and multitasking multiple projects in a fast-paced environment utilizing excellent time management skills
- Adept at working autonomously, as well as collaboratively in a dynamic team environment
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