Associate Director/Director, Regulatory Affairs

Location
94080, South San Francisco
Posted
Sep 27, 2018
Required Education
Bachelors Degree
Position Type
Full time

Associate Director/Director, Regulatory Affairs

Kezar Life Sciences – South San Francisco, CA

Kezar Life Sciences, a clinical stage biopharmaceutical, is looking for an experienced, dynamic, and motivated Associate Director or Director of Regulatory Affairs.   Kezar is focused on small molecule drug discovery and development to target autoimmune/inflammatory disorders and oncology based on the biology of protein homeostasis.  Our lead compound, KZR-616 (a selective inhibitor of the immunoproteasome), is in early stage clinical trials, and we have multiple drug discovery programs targeting protein secretion.  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 regulatory strategies and management of all 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.  If widespread involvement and impact in a young, dynamic company sounds appealing to you, please send your resume to: contact@kezarbio.com.

Essential Duties and Responsibilities:

  • Lead Regulatory Affairs activities with an emphasis on global regulatory strategy and 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
  • Function as primary liaison with health authorities and regulatory consultants including managing 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 leadership to resolve critical regulatory issues, bring the appropriate experts together as needed
  • Build a Regulatory Affairs department, manage budgets and project timelines, identify and address gaps in planning and resourcing
  • Provide overall organizational support as company grows its product development pipeline

Qualifications:

  • 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 and IMPD submissions; experience in NDA/MAA submissions highly preferred
  • Experience in eCTD format and structure
  • Knowledge of both GCP and GMP regulations
  • Strong analytical and strategic thinking skills, detail-oriented execution of work, and strong written and verbal presentation skills
  • Demonstrated excellence in regulatory liaison/strategy including a broad understanding of international regulations, processes and issues in drug development
  • Strong project management abilities
  • Able to work and communicate well within a multidisciplinary project team and to manage multiple projects simultaneously
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel), MS Project, and Adobe Acrobat