We have a current opportunity for a (Cell Therapy) Senior Director Regulatory CMC on a permanent basis. The position will be based in San Diego.
- Partnering with global health authorities
- Developing creative & innovative strategies
- Ensuring that CMC-related applications and/or sections are well written, and meet relevant requirements
- Partnering with cross-functional partners
- Effectively communicating regulatory CMC strategy, risks, mitigations, and overall plans to team members and partners
- Driving adherence to CMC regulatory guidelines for the development of cell therapy products
- Contributing to regulatory intelligence activities; monitor regulatory guidelines and trends; obtain and interpret global CMC regulations and guidance and provide regulatory advice to various internal teams and external partners as necessary
- Strong knowledge of current Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines including ICH, EMA, and FDA guidelines. Experience with the NPMA (National Medical Products Administration) in China, and other international regulations is ideal
- Experience in leading CMC topics at Health Authority meetings
- Excellent communication skills with the ability to influence across all functions and levels within the organization and with external stakeholders
- Excellent written and communication skills, strong technical knowledge, including CMC regulatory writing and ability to influence across multiple functions
- Self-motivated, self-disciplined, and able to function independently as well as part of a team
- Strategic agility, strong critical and logical thinking with ability to analyze and creatively solve challenging problems
- Strong organizational skills with the ability to prioritize, multi-task, and work in an evolving and fast-paced environment
For further information about this position please apply.