About SCG
SCG is a leading biotechnology company focusing on the development of novel immunotherapies in infections and its associated cancers. The company targets the most common cancer-causing infections: helicobacter pylori, HPV, HBV and EBV, and develops a broad and unique pipeline of TCR-based cellular immunotherapy products against infection- associated cancers. With the proprietary GianTCRTM TCR screening platform, in house viral vector production and AutoCellTM, a fully closed and automatic cell therapy manufacturing system, the company covers the entire value chain from new target research and discovery, manufacturing, and clinical development. For more information about SCG, please visit us at www.scgcell.com.
Position summary
The candidate is responsible for the development and implementation of post-approval global regulatory CMC strategies for a marketed cell and gene therapy product. This role provides regulatory guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into a marketed cell and gene therapy product.
Core responsibilities
- Leads and collaborates with individuals within Regulatory CMC to ensure robust and aligned CMC regulatory guidance is provided to cross-functional teams and stakeholders.
- Oversee submission processes and lead major applications (Investigational New Drug (IND) applications, IND amendments, Investigational Device Exemption applications, Clinical Trial Applications (CTAs), Biologic License Applications, Marketing Authorization Application and Pre-Market Approvals) as well as orphan designation applications (ODAs).
- Provide strategic direction to the teams and critical review of key Health Authority submissions such as IND/CTAs, meeting requests, briefing documents, response documents and marketing and supplemental applications.
Role requirements
- Bachelor's, Master's or PhD degree in Biology, Chemistry, Pharmacy, or another life-science field
- Requires 10 years of experience in the pharmaceutical or biotech industry or in a related field or the equivalent combination of education and experience. Cell and gene therapy experience is a plus.
- Individual must have prior project regulatory leadership experience with specific focus on the CMC aspects for small molecules, large molecules and/or cell/gene therapies, including detailed knowledge of FDA regulations and guidance for drug development, preparation and management of IND/CTA/MAA/NDA/BLA.