The Director, Regulatory Affairs, CMC will provide CMC regulatory expertise and support for development project work including CMC regulatory review for regulatory submissions and regulatory processes. This individual will represent CMC Regulatory Affairs on CMC and Regulatory Submission Teams, create timelines for complete and accurate IND/CTA and NDA/MAA submissions, ensure that clinical trials are designed to meet regulatory requirements, and guide programs to registration submissions. The individual must have the ability to work independently and also be an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
Essential Duties & Responsibilities
Valid through: 2020-3-4