Manager / Sr. Manager, Regulatory Operations

Manager / Sr. Manager, Regulatory Operations

The Manager / Sr. Manager, Regulatory Operations will report to the Director of Regulatory Operations and will work closely with the regulatory strategy leads, the regulatory operations vendors, and Kezar’s Veeva Vault System Administrator. The ideal candidate will be experienced in the successful planning, formatting, publishing, archival, and management of global regulatory submissions to support a growing biotechnology company. 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:

• Manage regulatory submissions (e.g., INDs, CTAs, IMPDs, Protocols and Amendments, Safety Reports, DSURs, Annual Reports, Meeting Packages, FDA Correspondence, etc.) in accordance with applicable regulations and Kezar processes
• Maintain proper archival of all regulatory submission documents (US, EU, and ROW) and related correspondence
• Until submission capabilities are brought in-house, serve as primary contact with external publishing vendor for planned regulatory submissions, communicating submission content and timelines
• Create content plans for upcoming and in-progress regulatory submissions
• Ensure completion of high-quality regulatory documents and submissions following regulatory guidelines and internal processes within expected timelines
• Maintain and update the suite of regulatory document templates and provide training to authors and ongoing support to functional groups
• Coordinate and supervise the QC of electronically compiled electronic submissions
• Participates in the interpretation and implementation of new health agency guidelines and rules relevant to regulatory submissions
• Ensure Kezar follows all regulatory technical guidance requirements for all submissions globally
• Manage document lifecycle in eCTD
• Contribute to development of process documentation including, SOPs, Work Instructions, and Best Practices related to Regulatory Operations
• Contribute to the evaluation, testing and implementation of regulatory tools, systems, and technologies
• Bachelor’s Degree in Life Sciences or related discipline, combined with 8+ years of relevant experience. Candidates at the Sr. Manager level would be expected to have additional years of experience. Overall industry experience will be considered in lieu of a degree.
• Relevant experience within a regulatory publishing environment including hands on eCTD experience and broad industry standard systems knowledge
• Expert knowledge of the eCTD structure and lifecycle management for INDs, CTAs, NDAs, and MAAs
• Excellent interpersonal communication and organizational skills
• Ability to multitask and work under pressure and tight deadlines
• Ability to function effectively in a global scientific and cultural arena
• Work independently under general supervision. Exercises judgment within defined practices and policies
• Experience with Veeva Vault RIM required; Veeva Vault certification, a plus
• Proficient in using MS Office Suite, Adobe Acrobat and ISIToolBox, SharePoint, EndNote, Accenture StartingPoint Templates, and other relevant tools
• Knowledge of applicable FDA, EU and ICH guidelines related to regulatory submissions, clinical trials and marketing applications
• Continuous quality improvement mindset and attention to details
• Must possess flexibility to work effectively within an environment that has quickly changing priorities and deadlines

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 Sciences or related discipline, combined with 8+ years of relevant experience. Candidates at the Sr. Manager level would be expected to have additional years of experience. Overall industry experience will be considered in lieu of a degree.
• Relevant experience within a regulatory p