Regulatory and Compliance HC Specialist 4 - San Francisco, United States - University of California San Francisco

Description

Regulatory and Compliance HC Specialist 4
Laboratory Medicine

Full Time

76861BR

Job Summary

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 therapies (preferred) and/or biologic therapeutics, and coordination of regulatory activities 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 preclinical studies. Liaises regularly with the FDA to ensure that timelines are consistently met.

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 )

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:

Department Description

The Department of Laboratory Medicine houses the UCSF Clinical Laboratories, top-tier teaching programs for residency, fellowship, and professional training, and a robust biomedical research community that spans specialties such as hematology, immunology, microbiology, transfusion medicine, and genomics. The Department also maintains a cutting-edge cell and gene therapy program developing, manufacturing, and delivering a wide variety of standard-of-care and investigational products for UCSF and partner institutions. This program is bolstered by dedicated Process Development and Good Manufacturing Practice (GMP) facilities and is orchestrated by a multidisciplinary team that brings together medical, manufacturing, quality, scientific, and regulatory expertise. In collaboration with UCSF Alpha Clinic and the Living Therapeutics Initiative, the program is committed to driving rapid innovations in academic cell and gene therapy development.

Required Qualifications

6+ years of regulatory affairs experience in the biopharmaceutical industry or equivalent Pref Knowledge of regulatory requirements and early to mid-clinical stage experience with US regulatory submissions for therapeutic products (IND/BLA), including knowledge of the methods, tools, and practices involved with regulatory compliance.
Experience with either cellular therapy (preferred) or biologic therapeutic development, manufacturing and clinical trials.
Experience with authoring, review, and editing high-quality regulatory documents
Demonstrated a successful track record of effectively moving products through the development process.
Thorough understanding of US regulations related to these regulatory pathways.
Expert knowledge of domestic regulations and guidelines and industry best practices and standards in regulatory affairs.
Experience with major submissions, including IND.
Ability to interact effectively across all levels of the organization, meet priorities and deadlines in alignment with project priorities and proven ability to apply project management principles and best practices.
Ability to problem-solve complex issues across cross-functional teams including advanced interpersonal skills for collaborating effectively at all levels and with representatives of external regulatory agencies.
Excellent organizational skills that enable the successful execution of multiple simultaneous projects
Strong knowledge and understanding of compliance and regulatory standards across the cellular therapy and/or biologic therapeutic healthcare industry.
Advanced skills in written and verbal communications, with the ability to convey highly-complex technical information, education, and instructions in a clear and concise manner, and to produce high-quality reports, documentation and presentations.

Preferred Qualifications

PhD preferred.