Sr. Manager / Associate Director, Regulatory Affairs

Company: Kezar Life Sciences
Location: San Francisco
Posted on: January 16, 2022

Job Description:

Kezar Life Sciences (NASDAQ: KZR), a clinical-stage biotechnology sciences company located in South San Francisco, is seeking a Sr. Manager/Associate Director, Regulatory Affairs. The Sr. Manager/Associate Director will report to the Sr. Director, Regulatory Affairs and will be responsible for management of the regulatory development activities for assigned products. The ideal candidate will be experienced with working in a global clinical development environment, will be self-motivated, highly accountable, professional, and dedicated to support a growing biotechnology company.

Kezar is focused on small molecule drug discovery and development to target immune-mediated diseases and cancer. Kezar's lead product candidate, KZR-616, a selective inhibitor of the immunoproteasome, is being evaluated in Phase 2 clinical trials for the treatment of severe autoimmune diseases. KZR-261, Kezar's first oncology candidate targeting the protein secretion pathway via the Sec61 translocon, is now being studied in a Phase 1 clinical trial in several oncology indications.

Responsibilities
Develop, review and/or file INDs, CTAs, briefing documents and maintenance of development and approved applications, including DSURs, annual reports, and IND amendments, as needed.
Provide regulatory representation and global strategic insight and expertise on cross-functional project teams and in sub-team meetings.
Collaboratively assist in the development of global regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs.
Maintain an awareness, through regulatory intelligence, of global regulatory strategies for products in the same class/indication and determine applicability to Kezar's programs.
Ensure accurate and timely compilation and submission of regulatory documentation.
Manage study-start regulatory activities/submissions, including management of CRO counterparts, to complete submissions and respond to queries to obtain regulatory authority CTA approval.
Provide regulatory review of clinical study documentation, including review of clinical protocols, informed consent documents, and clinical study recruitment materials.
Review essential documents for regulatory green light for opening new clinical trial sites and sign off on IP shipments.
Review of labeling revisions for assigned program.
Ensure global regulatory compliance standards and commitments are met.
Responsible for leading, developing, driving and maintaining regulatory and technical sections of global CTD filings to ensure compliance of global filings in line with company scientific data.
Effectively monitor and ensure applicable regulatory requirements are considered and appropriately incorporated into all programs, ensuring compliance with appropriate regulations and guidelines.
Other duties as assigned.

Requirements
Bachelor's Degree in Life Science or other related discipline. Advanced degree preferred. Equivalent combination of education and applicable job experience may be considered.
Minimum of 7 years' regulatory experience in the pharmaceutical and biotechnology industry.
Ability to work independently with minimal direction, including functional representation within project teams in order to attain group goals.
Thorough understanding of FDA regulations, ICH guidelines, and the drug development process, INDs, CTAs, NDAs, and/or MAAs.
Experience in rare disease space, a plus.
Strong 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 direct and manage multiple projects and complex timelines in a team environment.
Excellent interpersonal communication, analytical and organizational skills.
Ability to function effectively in a global scientific and cultural arena.
Experience in regulatory CMC, a plus.
Ability to lead, train, and mentor team members at all levels.
Ability to travel 10-20% domestic and international.
Strong computer skills; Experience with Veeva Vault, preferred.

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