Senior Associate, Regulatory Affairs
- Kezar Life Sciences
- South San Francisco, California
- Start date
- Feb 26, 2023
- Regulatory, Regulatory Affairs
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Biotech Bay
Kezar Life Sciences is seeking a Senior Associate, Regulatory Affairs. This position will report to the Senior Manager, Regulatory Affairs and will be responsible for supporting the regulatory development activities for assigned investigational products and will assist in the development of relevant sections of global core dossiers for assigned products. This position will attend and participate in cross-functional and department team meetings. Key accountabilities include assisting with the preparation of various regulatory documents for regulatory agencies, tracking the status of submissions, and collaborating with cross-functional teams to ensure compliance with regulatory requirements. The expectation is to be onsite at our South San Francisco, CA office at least three days per week.
Kezar is focused on small-molecule drug discovery and development to target immune-mediated diseases and cancer. Kezar’s lead product candidate, zetomipzomib, is being evaluated in clinical trials for the treatment of lupus nephritis and autoimmune hepatitis. Kezar is also conducting an oncology clinical trial of KZR-261, the first candidate from its novel platform targeting the protein secretion pathway. This research platform has the potential to generate additional small molecule compounds with therapeutic potential in cancer and inflammation.
Key Responsibilities include:
- Assist in the preparation and submission of regulatory documents, such as investigational new drug applications (INDs) and amendments, to regulatory agencies.
- Assist with creating and maintaining regulatory timelines and tracking deliverables to timelines to ensure regulatory submission timelines are met.
- Interface with functional areas (Research [preclinical], Clinical, Manufacturing, QA, QC, and Regulatory Operations) to identify and obtain information required for regulatory submissions.
- Assist in study-start regulatory activities/submissions, including assisting CRO counterparts, to complete submissions and respond to queries to obtain global regulatory authority CTA approvals.
- Track the status of regulatory submissions and provide updates to internal stakeholders.
- Support development of DSURs, annual reports, and updates to the investigator’s brochure for assigned product(s).
- Perform literature searches and other research to extract information to support regulatory submissions.
- Review and assess regulatory impact of changes to products and processes.
- Maintain up-to-date knowledge of global regulatory requirements and guidance.
- Support regulatory intelligence applicable to Kezar’s programs by reviewing and summarizing global regulatory strategies for products in the same class/indication.
- Ensure accurate and timely compilation and submission of regulatory documentation.
- Provide regulatory review of clinical study documentation, including review of clinical protocols, informed consent documents, and clinical study recruitment materials.
- Assist in the review of essential documents for regulatory green light for opening new clinical trial sites and sign off on IP shipments.
Not sure if you are qualified for this position? We know that skills and experience can show up in different ways and we welcome resumes from a broad range of applicants. You are encouraged to apply even if you do not meet each of the listed preferred qualifications.
Preferred Qualifications Include:
- Bachelor’s Degree in Life Science or related discipline with approximately 2 years of regulatory experience in the pharmaceutical or biotechnology industry. Equivalent combination of education and applicable job experience may be considered.
- Knowledge of global regulatory requirements and guidance, including FDA regulations, ICH guidelines, and the drug development process, INDs, CTAs, NDAs, or and or MAAs.
- Understanding of FDA structure and function.
- Self-starter with ability to work independently with minimal direction.
- Excellent written and verbal communication skills.
- Highly motivated with excellent interpersonal communication, analytical and organizational skills.
- Strong attention to detail and ability to multi-task.
- Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency; ability to support multiple projects and complex timelines in a team environment.
- Experience in rare disease space, a plus.
- Ability to travel 10-20% domestic and international.
- Strong computer skills: Experience with Veeva Vault, preferred.
Compensation and Benefits
The salary range for this position as Senior Associate, Regulatory Affairs at our South San Francisco, CA corporate office is $95,000 - $105,000. Factors such as academic credentials and relevant experience will influence the actual salary offered. In addition to a competitive market-based salary, Kezar Life Sciences offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package including 401K. Additional information about our total rewards program can be found here: Join Our Team - Kezar Life Sciences Inc.
About Kezar Life Sciences
We are developing first-in-class, small molecule therapies designed to inhibit multiple disease-driving cellular pathways by targeting key intracellular proteins. Since inception, our mission has been to deliver unique treatments that can better the lives of patients fighting difficult-to-treat chronic diseases. Our team is passionate about discovering promising targets that were previously unidentified or undruggable and have the potential to change the treatment paradigm for a range of conditions.
Here at Kezar, our employees are our greatest asset and are the drivers of the Company’s success. Every day, our team of passionate professionals are converting scientific ideas to first-in-class assets that have the potential for significant clinical impact in the most difficult-to-treat diseases. Together, we are focused on the common mission of helping patients overcome their chronic conditions and live a better life.
We believe in fostering a culture of trust and respect for all team members at all levels. Our employees are encouraged to question, exchange views and discover new ways to address issues and solve problems. We welcome differences in ideas, styles and practices to accomplish our goals. Hard working, innovative and compassionate are qualities every Kezar employee should possess and we’re always looking for equally dynamic and motivated individuals to join our team.
Information for Recruitment Agencies
Kezar Life Sciences does not accept from recruiters/agencies any unsolicited resumes, or any candidate information including blinded resumes and will not be responsible for any fees related to resumes or candidate information that is unsolicited. Please do not contact hiring managers or Kezar Life Sciences employees directly with any information related to a resume or a candidate. We handle all recruiting through our internal Human Resources team, and we will reach out to you directly should we wish to engage in a search. Your willingness to comply with this will significantly impact any decision we may make about doing business with you.
4000 Shoreline Ct
South San Francisco
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