Senior Manager/Associate Director

Senior Manager/Associate Director, Regulatory Affairs

DESCRIPTION

Kezar Life Sciences (NASDAQ: KZR), a clinical stage biopharmaceutical company, is seeking an experienced, dynamic, and highly motivated Senior Manager/Associate Director of Regulatory Affairs who will provide support to the Senior Director, RA. Kezar is focused on small molecule drug development and discovery to target autoimmune/inflammatory disorders (lupus/lupus
nephritis, dermatomyositis/polymyositis, autoimmune cytopenia) and oncology based on the biology of protein homeostasis. Our lead compound, KZR-616 (a selective inhibitor of the immunoproteasome), is in Phase 2 clinical trials, and we are planning for expansion into other indications. We have multiple drug discovery programs targeting protein secretion, and one drug candidate (KZR-261) that is completing IND-enabling activities with plans to conduct the first-in-human oncology study starting in 2021. This is an exciting time to help drive the development of novel therapies for unmet needs in multiple indications.

This position will be responsible for assisting with regulatory strategy, contributing to Agency meetings, and management of worldwide regulatory submissions and responses. In this role, emphasis will be on proper strategic and operational planning, collaboration with development
team members, and execution on all aspects of regulatory affairs.

Essential Duties and Responsibilities:

  • Global Regulatory Affairs activities and management of CRO activities; lead the preparation, review and submission of documents to the FDA and other regulatory authorities
  • Work with multidisciplinary project groups in meeting established objectives; prioritize projects to meet internal and external deadlines; and provide regulatory guidance to key stakeholders at all levels of the organization
  • Assist in development of regulatory authority meeting requests, briefing documents, and preparation for regulatory meetings
  • Manage the internal review and approval process for submissions and regulatory questions and responses
  • Manage internal meetings around regulatory submissions and maintain internal trackers and databases, as appropriate
  • Provide support for pharmacovigilance-related regulatory interactions
  • Provide support to resolve critical regulatory issues, bring the appropriate experts together as needed

Requirements:

  • Bachelor’s degree in a life sciences, chemistry, or related discipline, advanced degree preferred
  • Regulatory affairs certification (RAC) a plus
  • 5+ years of hands-on Regulatory Affairs experience involving successful IND/IND amendment submissions; experience in NDA/MAA submissions highly preferred
  • Experience in eCTD format and structure
  • Knowledge of the drug development process (early stage through commercialization)
  • Experience in successfully leading submission teams
  • In-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for global territories and have an in-depth understanding of current global and regional trends in Regulatory Affairs
  • Ability to work independently and prioritize tasks, with strong drive to deliver high-quality work on a tight timeline CMC and/or Device experience a plus
  • Veeva Vault document management experience preferred
  • Able to work and communicate well within a multidisciplinary project team and to manage multiple projects simultaneously; collaborative team player with a desire to make an impact
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel), MS Project, and Adobe Acrobat

For more information, please contact us at HR@kezarbio.com

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Accepted formats: PDF, Word Doc

Accepted formats: PDF, Word Doc