Manager, Regulatory Affairs
Employment Type: Full-Time
Regulatory Affairs Manager
Instil Bio is a global clinical-stage biotechnology company focused on the development of novel immuno-oncology treatments called tumor infiltrating lymphocytes (TILs). TILs are naturally occurring immune cells with the ability to identify and destroy cancer cells. Instil Bio is engineering TILs to harness and amplify their cancer fighting ability to treat of a broad range of solid tumor cancers. Instil Bio is located in southern California with additional manufacturing and research facilities in Manchester U.K.
We are seeking a highly motivated, self-starter to support advancement of the companys lead TIL candidate as we initiate clinical trials for the treatment of solid tumors. The successful candidate will join a Regulatory team tasked with meeting regulatory requirements, engaging, and maintaining relationships with global health authorities, and keeping up to date with the evolving regulatory landscape to guide company strategy. In this role, the Regulatory Affairs Manager will be expected to manage routine regulatory submissions such as safety reporting and annual reports and generate regulatory intelligence summaries.
Responsibilities (include but not limited to):
* Develop US regulatory strategy to align with the global regulatory strategy for our lead product
* Lead US regulatory submissions (ex, INDs, FDA Meeting Requests) and provide support on ex-US submissions in accordance with local and regional requirements.
* Format, compile, and review regulatory submissions for completeness and quality. Ensure that submissions meet eCTD technical conformance standards.
* Assist with logging, tracking, and archival of correspondence and submissions to/from health authorities.
* File regulatory documents to the clinical study TMF and ensure that regulatory documents are in an inspection ready state.
* Collect, organize, and interpret information on regulatory requirements to meet applicable regulations and to assist in developing regulatory strategy.
* Collaborate on cross-functional study teams to coordinate and implement regulatory submission strategy and escalate issues to management when needed.
* Support review of documents intended for health authority submissions such as protocols, reports, and investigators brochures to ensure compliance with relevant FDA and ICH regulations and guidelines.
* Analyze information from a variety of sources to generate regulatory intelligence summary reports
Requirements and Recommendations:
* BS or BA; scientific discipline is preferred
* Minimum of 4 years of regulatory experience. Experience with oncology drug development is preferred.
* An ideal candidate will possess all the following:
* Knowledge of FDA & ICH requirements as they pertain to investigational drug development.
* Working knowledge of eCTD submissions
* Knowledge of clinical trials
* Strong project management skills.
* Above average attention to detail
* Outstanding organizational skills with the ability to multi-task and prioritize.
* Excellent interpersonal, written, and verbal communication skills to support communications internally and externally with health authorities
* Ability to work independently on assigned projects.
* Demonstrated problem-solving and critical thinking skills
* Technical Skills:
* Microsoft Office Suite proficiency