Careers

Director/Senior Director/Executive Director, CMC Regulatory

Location: San Mateo, CA

POSITION

  • CMC Regulatory expert with responsibility for leading the strategy, management, and tactical execution of the CMC regulatory activities, ensuring that all applicable CMC-related regulations and guidelines are followed in the US and globally.
  • Proactively partners with the Head of Regulatory on the development of the regulatory strategy and Technical Operations counterparts on processes and program prioritization.
  • Direct influence on the decision-making processes within the scope of CMC related activities.
  • Effectively leads CMC focused meetings and topics with US and global health authorities to ensure full discussion of issues and opportunities.
  • Represent CMC Regulatory on project teams.
  • Manage CMC regulatory direct reports, including FTEs and/or consultants, CROs.
  • Work independently and collaboratively as a key team member in a fast-paced, small company environment.

ESSENTIAL FUNCTIONS AND DUTIES

  • Functions as the CMC Regulatory Head, working with other Regulatory colleagues to drive regulatory strategies,
  • Provide strategic guidance into the development of robust CMC strategies for multiple projects across the product life cycle.
  • Manage timelines in cooperation with SMEs and project management to ensure on-time regulatory submissions.
  • Lead and participate in the planning, organizing, and managing of the CMC content of meetings with global regulatory agencies.
  • Assist with the planning, scientific writing, and perform critical reviews of pre-INDs, INDs, IMPDs, CTAs, NDAs, BLAs, MAAs, annual reports, DSUR, amendments, supplements to ensure high quality regulatory submissions and approvals.
  • Support establishing, managing, and maintaining a knowledge base of current and emerging CMC regulatory requirements and guidelines.
  • Perform regulatory assessment of change controls, deviations and GMP investigations.
  • Manage multiple concurrent projects and provide timely project updates.
  • Track CMC regulatory commitments for INDs/IMPDs, CTAs, and NDAs/BLAs/MAAs.
  • Lead CMC project team meetings.
  • Recruit, develop, manage, and mentor regulatory professionals and drive a culture of excellence that motivates employees to perform at their highest ability.
  • Leads and/or participates in regulatory and technical operation initiatives to improve processes and ways of working, keeping current with approaches to regulatory strategy and submissions.
  • Perform other duties as assigned.

SKILLS AND EXPERIENCE

  • Requires a Bachelor of Science degree plus a minimum of 8-15 years of industry experience in US and global regulatory CMC activities or equivalent combination of education and experience.
  • Knowledge of global (US, EU, ROW, ICH, etc.) regulatory requirements.
  • Small molecule and biologics CMC submission experience preferred.
  • 5+ years of management experience preferred.
  • Must be able to demonstrate the ability to apply knowledge strategically and operationally across all projects.
  • Experience working in a matrix environment: strong negotiation skills, able to communicate sound regulatory advice based on regulations.
  • Previous experience in providing regulatory assessment of change controls, deviations and GMP investigations.
  • Ability to work in close collaboration with colleagues in the Regulatory department and throughout the organization.
  • Embodies Kronos Bio 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.