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
Position requirements:
Master’s degree in a life science discipline required, Ph.D./PharmD preferred
Average of 5+ years of relevant experience in regulatory affairs, preferably in neurology and/or oncology
Strong experience in IND and CTA filings. Experience in NDA/BLA/MAA preparation preferred
Strong understanding of international regulations/guidance and overall drug development process
Experience in managing projects that involve close interactions with external collaborators
Exceptional planning/organizational and analytical skills, with ability to work simultaneously on multiple projects with tight timelines
Exceptional influencing, partnership, and collaboration skills
Strong interpersonal and communication skills
Able to prospectively identify potential problems and to partner effectively and positively to solve issues with cross-functional team
Internal Number: 238
About Calico
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.
