Who we are:

Calico is a research and development company whose mission is to harness advanced technologies to increase our understanding of the biology that controls lifespan. We will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Executing on this mission will require an unprecedented level of interdisciplinary effort and a long-term focus for which funding is already in place.

Position description:

The Calico Regulatory Affairs Manager/Sr. Manager, reporting to the Head of Regulatory, will fill the role of a Regional Lead accountable for the regulatory management of one or more clinical development program(s).

• Plays a key role in developing the regulatory strategy and ensuring its technical execution cross-functionally for assigned development programs, in line with program goals and objectives
• Responsible for identifying regulatory risks and mitigation plans
• Assists with management of Health Authority interactions
• Independently executes preparation, submission, and maintenance of regulatory applications, including initial IND/CTA, routine amendments, annual reports, IND safety reports, and correspondence with global Health Authorities
• Maintains archiving and tracking of ongoing submissions
• Participates in cross-functional meetings within and outside of Calico, providing regulatory guidance and support
• Partners with external vendors/collaborators in support of regulatory document preparation and submission
• Conducts research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy and proactively assesses impact of changes on development plan
• Complies with relevant governing laws, regulations, guidelines, and supports development of Calico SOPs