Manager, Regulatory Professional
Regulatory Affairs | Santa Monica, CA | Full Time
Kite Pharma is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team. Kite is publicly traded (NASDAQ: KITE) with a current market well over $2 Billion.
The Regulatory Professional will assist in the creation and submission of regulatory documents.
Duties and Responsibilities (include but are not limited to):
- Ensure submission-readiness of all regulatory documents
- Ensure that documents to be submitted to the health authorities are compliant with eCTD submission requirements.
- Format documents per Kite Style
- Track formatting tasks for regulatory documents across Kite programs
- Create/maintain document templates
- Lead the submissions of SUSARs to the health authorities, including Recombinant DNA Advisory Committee (RAC)
- Create and maintain global safety submission tracker
- Lead the submission of IND amendments regarding new investigators
- Maintain product regulatory history/commitment trackers
- Manage clinical trials.gov site maintenance
- Create relevant submissions in SPL format
- Basic Qualifications: Bachelor’s degree and 2 years of regulatory/drug development experience
- Good communication skills – both oral and written
- Organizational skills – detail oriented and can deal with frequent changes in product activity
- Strong knowledge of eCTD elements and structure
- Strong team player that has a customer service approach and is solution oriented
- Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- High level of proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
- Expertise with templates and formatting tools
- High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
- Willingness to think outside of the box and adapt best practices to our small, but growing environment
- Ability to adapt in a constantly evolving environment
- Self-motivated with a strong sense of ownership in areas of responsibility
- High degree of professionalism, ethics and integrity
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Kite Pharma, an equal opportunity employer, is located in beautiful Santa Monica, CA just steps from Santa Monica Blvd and right off the 10. We are able to offer the opportunity to be part of the first 500 employees in this successful, fast growing company. To learn more about us, please visit our website at www.kitepharma.com.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.
No phone calls from recruiters or agencies please.