Careers

Associate/Senior Associate, Regulatory Affairs

Location: San Mateo, CA

POSITION

  • Supports day-to-day regulatory activities of assigned projects
  • Supports preparation and compilation of submissions for regulatory agencies
  • Supports and/or manages regulatory submissions processes and timelines
  • Supports regulatory start up and maintenance activities for global clinical studies, responsible for maintaining regulatory tracking tools, archives, and infrastructure, as assigned
  • Represent Regulatory Affairs at Study Management Team (SMT) meetings, as needed

ESSENTIAL FUNCTIONS AND DUTIES

  • As regulatory representative/support for assigned clinical studies, provides representation for study-level regulatory activities and updates in study team management meetings, supports clinical trial application activities, reviews and approves investigator document packages including FDA submissions, and manages other regulatory aspects of study as directed
  • Manages and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding unfulfilled conditions/commitments
  • Collaborates with Project Team representatives and regulatory staff in planning of regulatory documents including responses to Health Authority queries. Supports processes by which regulatory submissions are reviewed, finalized, signed-off, and submitted
  • Manages tracking of regulatory submissions and approvals across all studies
  • Manages document archive processes
  • Builds increased awareness and knowledge of international pharmaceutical guidance’s, regulations, drug development process, and industry standard practices; Applies knowledge to projects
  • Interacts collaboratively with CROs in the management of US eCTD IND submissions and ex-US CTAs towards clinical trial activations

SKILLS AND EXPERIENCE

  • Experience interacting with CROs in the management of US eCTD IND submissions and ex-US CTAs towards clinical trial activations preferred
  • BA/BS degree in the biological or physical sciences preferred
  • Relevant pharmaceutical industry experience including 1-2 years of experience in regulatory affairs. Minimum requirements are flexible
  • Proficient in written, oral, and interpersonal communications in English
  • High attention to detail; ability to organize, prioritize, and delegate assigned projects
  • Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems and document review tools desirable
  • Ability to work in close collaboration with colleagues in regulatory department and throughout the development organization
  • Embodies Kronos values; exhibits high degree of integrity and professionalism when interacting with colleagues and external customers
  • Entrepreneurial and enjoys working in a fast-paced, creative, and resourceful small company environment

To apply for this position, please forward your resume and cover letter to careers@kronosbio.com.