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Regulatory and Compliance HC Specialist 4

University of California San Francisco

Details

Posted: 15-Nov-23

Location: San Francisco, California

Type: Full-time

Salary: Open

Internal Number: 75169BR

The Living Therapeutics Initiative seeks a highly motivated Regulatory Affairs Senior Manager to manage the regulatory affairs, author and assemble IND applications, and help manage FIH studies advancing UCSF-developed cellular therapy candidates. The successful candidate will work in a dynamic academic environment, working across various departments and collaborating closely with our CDMO partner. The position requires previous regulatory experience with cellular and gene therapies and coordination of regulatory activities, including manufacturing, toxicology, and clinical aspects of the studies. A project manager approach to managing regulatory benchmarks is essential. The candidate must be able to work within a fast-paced environment and will participate in regulatory strategy and execution. This position requires a high degree of confidentiality and is charged with handling and relaying sensitive information and findings.

Applies extensive knowledge of healthcare industry regulatory affairs concepts to substantial projects of large scope and high degrees of complexity. May be a lead or resource in a specialty discipline.

In support of cellular and gene therapy programs at UCSF, manage the necessary documentation, submissions, and communications with the FDA for successful IND submissions and in support of clinical studies. Provide guidance across cross-functional teams for CMC regulatory strategy and ensuring complete CMC and pharm/tox packages, along with assisting teams with generating submission-ready content for Quality/CMC and Pharm/tox sections of investigator-initiated research projects. Liaises regularly with the FDA to ensure that timelines are consistently met. Having a working knowledge of the eCTD format for filing and organizing INDs is highly desirable.

To see the salary range for this position (we recommend that you make a note of the job code and use that to look up): TCS Non-Academic Titles Search (ucop.edu)

Please note: The compensation ranges listed online for roles not covered by a bargaining unit agreement are very wide, however a job offer will typically fall in the range of 80% - 120% of the established mid-point. An offer will take into consideration the experience of the final candidate AND the current salary level of individuals working at UCSF in a similar role.

For roles covered by a bargaining unit agreement, there will be specific rules about where a new hire would be placed on the range.

To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html

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About University of California San Francisco

The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and high-quality patient care. It is the only UC campus in the 10-campus system dedicated exclusively to the health sciences.

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