Upvote
Downvote
Vice President, Regulatory Affairs, CMC
Share Job
- Suggest Revision
- The Vice President of CMC Regulatory Affairs is leading the Ultragenyx’s CMC Regulatory Affairs function.
- Ultragenyx have an exciting portfolio with both marketed, late and early-stage projects across Gene Therapy, Biologics and small molecules for Rare Diseases.
- In addition, the leader will be recognized as a global thought leader for regulatory science and be accountable for leading the interpretation and implementation of CMC regulatory guidelines, regulations and current environment to assure approvability in high priority regions.
- Lead global CMC regulatory strategies for projects in development and marketed products, including risk mitigation strategies to ensure approvals and maintenance of product licenses.
- Strengthen internal gene therapy CMC capability by working with internal stakeholders and external partners to evaluate and enable gene therapy related GTP/GMP facility
Active Job
Updated TodaySimilar Job
Relevance
Active