Cambrian Biopharma, a multi-asset longevity biotech, is building the medicines that will redefine healthcare in the 21st century – therapeutics to lengthen health span, the period of life spent in good health.
By partnering with leading academic institutions and biotech entrepreneurs worldwide, we are advancing a diversified pipeline of novel therapeutics, each targeting a biological driver of aging. Our approach is to develop interventions that treat specific diseases first, then deploy them as preventative medicines to improve the overall quality of life as we age.
Cambrian is a Distributed Development Company (or DisCo) that combines the advantages of a venture capital firm and a big pharmaceutical company with the nimbleness of a biotech startup.
Cambrian's sourcing and development engine allow us to identify promising science, deploy capital and teams of drug development experts, and provide stewardship to advance new medicines. By leveraging established expertise and repeatable functional models, we achieve vast efficiencies in execution speed and resource utilization.
To date, we have 14 novel therapeutics in development and have closed a Series C financing round in October 2021, which raised $100 million. We plan to expand the number of programs. Further, we expect to initiate clinical trials for some of our three programs in the upcoming months.
The Director of Regulatory Affairs will be responsible for developing regulatory strategies, leading Agency interactions, and preparing regulatory submissions for Cambrian’s portfolio of projects. The Director will work with Cambrian’s R&D and Clinical Development teams to develop regulatory strategies and plans that align with company goals and to leverage an external CRO network to deliver high quality submissions. This individual will be responsible for staying abreast of changes in the global regulatory environment and assessing and communicating the impact on the Cambrian portfolio.
Provides strategic regulatory direction on projects including developing the overall regulatory plan, advising on regulatory requirements for development plans, study designs and marketing approval, conducting risk assessments, and managing critical issues and Health Authority interactions.
Leads the successful implementation and execution of regulatory plans to support project approval and commercialization.
Identifies, manages and oversees a network of Regulatory CRO partners which meet the needs of the portfolio
Harnesses knowledge of US, EU and ICH regulatory requirements to strategically and operationally resolve regulatory issues impacting development programs to ensure business goals are met.
Builds partnerships with key senior stakeholders from other functions to ensure that strategic business goals are met through sharing of knowledge, expertise and provision of appropriate resources.
Liaises and influences US FDA, EMA, and other regulatory agencies as needed for all aspects pertaining to drug development including novel regulatory pathways, resolution of key regulatory issues and to expedite progression of projects.
Takes a hands-on approach in leading the completion of IND/CTA, NDA/BLA/MAA, and other global submission documents.
Serves as a subject matter expert on relevant global regulations, stays abreast of changes in the global regulatory environment, and assesses impact of changes on business and product development projects.
Proactively manages critical issues, taking leadership for regulatory contribution.
Supports the development of relevant policies, processes, and SOPs.
Provides regulatory due diligence assessments of new opportunities as required.
Minimum MS, PhD or PharmD Degree with 7-10 + years regulatory experience in pharmaceutical industry.
Extensive hands-on regulatory experience, including managing IND/CTA and BLA/MAA submissions,
Extensive experience in interacting with Health Authorities especially the FDA.
Experience in multiple disciplines (Clinical Quality, Nonclinical) is strongly preferred.
Ability to develop and implement complex global regulatory strategies.
Strong scientific foundation, including a strong understanding of the development of small molecules and ATMPs
Practical understanding, interpretation, and application of relevant ICH, FDA and EMA guidelines and regulations.
Excellent verbal and written communication skills; able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates issues to internal and external stakeholders, including Senior Management.
Ability to develop creative solutions
Ability to prioritize and handle multiple projects simultaneously.
Opportunities to shape new and exciting science and build teams that bring novel therapeutics to patients in need
Exposure to the biotech company life cycle and industry
A dynamic, mission-driven, and entrepreneurial company culture
Access to our network of international decision-makers and investors
Competitive salary + equity
16 company holidays and an unlimited PTO policy
Multiple health, vision, and dental insurance plans to choose from, including no-monthly-premium options supporting individuals and families
Cambrian Biopharma is proud to be an equal employment opportunity and affirmative action employer. We celebrate diversity and do not discriminate based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training