Decoding Biology to Radically Improve Lives
Director, Regulatory Affairs
Location
United States
Posted
4 days ago
Salary
$207.5K - $280.7K / year
Seniority
Lead
No structured requirement data.
Job Description
Director, Regulatory Affairs
Recursion
Role Description Your work will change lives. Including your own. The Impact You’ll Make: Recursion is at the forefront of reimagining drug discovery and development through broadening the funnel of potential targets, using technology and standardization to build connected data, and superlinearly scaling our efforts to accelerate the delivery of high-potential drug candidates to the clinic. We are seeking a Director of Regulatory Affairs who will play a critical role in supporting global regulatory strategy, overseeing processes, and identifying and managing regulatory risks for the assigned programs. - Build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization to ensure management of regulatory strategy and activities in all applicable regulatory jurisdictions (e.g. EU, US, UK) for the global development of products through all stages of development and post-approval. - Participate in global product team meetings; provide regulatory support and guidance and manage day-to-day regulatory activities. - Manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion while practicing sound judgment as it relates to risk assessment. - Create and follow procedures for regulatory execution and implementation of regulatory strategies while actively supporting program leads via the Clinical Study Teams (CSTs) to deliver on business objectives for assigned products/programs. - Create, collaborate and comply with disclosure and transparency policies for applicable jurisdictions. - Collaborate with strategic operations and other functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide regional regulatory insight for futuristic planning and considerations for the program. - Serve, as needed, as the point of contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders. - Review and interpret regulatory guidelines and create a communication plan to distribute relevant impact assessment. - Creatively think outside the box on how to influence and shape the future of regulatory sciences as it relates to use and validation of unprecedented use of technology to develop drugs effectively for faster paths to patients. - Keep current with regulations and guidance documents; attend meetings, seminars, conferences on relevant topics; read journals, newsletters, scientific papers; research the answers to RA questions. - Represent regulatory function and demonstrate respectful behavior, leadership, ethics and transparency. Qualifications - A minimum of 10 years in the pharmaceutical industry with a minimum of 8 years in Global Regulatory Affairs. - Experience with major Health Authorities (US FDA, Health Canada, UK MHRA and EMA) is mandatory. - Oncology, rare disease, and I&I experience is good to have. - Minimum of 8 years experience with regulatory submissions (e.g. INDs, NDAs, post marketing measures, PIPs, ODD, BTD, EU PRIME activities) are mandatory. - Strong understanding of regulatory strategy and implementation of operational activities. - Outstanding management, interpersonal, communication, negotiation, and problem-solving skills. - Demonstrated proficiency in organizational awareness, including experience working cross-functionally and on global teams. Requirements - This role is remote-friendly, with most work conducted from home. - There may be occasional opportunities or expectations for travel to our Salt Lake City headquarters or other office locations. Benefits - Estimated annual base salary range for New York City, Boston, & San Francisco Bay Area(s): $228,250–$280,720. - Estimated annual base salary range for Salt Lake City & all other U.S. locations: $207,500–$255,200. - This role is eligible for an annual bonus, equity compensation, and a comprehensive benefits package. Company Description Recursion (NASDAQ: RXRX) is a clinical-stage TechBio company decoding biology to radically improve lives. Recursion is advancing a portfolio of differentiated investigational medicines across its wholly owned and partnered pipeline in oncology, rare disease, neuroscience, immunology, and other therapeutic areas with significant unmet need. Enabling its mission is the Recursion OS, an AI-native, end-to-end drug discovery and development platform integrating biology, chemistry, and clinical development into a unified intelligence system. Recursion’s platform infrastructure is anchored in Salt Lake City, Utah and Milton Park, Oxfordshire, where its automated biology and chemistry laboratories generate proprietary data at industrial scale. Recursion also maintains offices in New York, Montréal, and London, three global hubs for talent and leadership at the intersection of AI and scientific innovation.
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