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.