Associate Director of Regulatory Affairs

Your work will change lives. Including your own.The Impact You'll MakeRecursion 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 an Associate 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. Collaborate with cross-functional leads to support the development of regulatory strategies and implementation for all jurisdictions as applicable to the program. Plan and perform critical reviews of documents for consistency and quality, and identify gaps in critical documentation in alignment with the regulatory strategy with the intention of achieving successful registration and lifecycle management of unique this role, you will: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 jurisdiction (e.g. EU, US, UK and other) 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 activitiesManage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion while practicing sound judgment as it relates to risk assessment (immediate and long term impact on program)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 productsprograms (e.g. clinical trial applications, marketing authorization applications, orphan drug designation applications, pediatric submissions, etc.). Create, collaborate and comply with disclosure and transparency policies for applicable jurisdictionsCollaborate with strategic operations and other functions (e.g. Clinical, CMC, 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 andor lead interactions with such authorities or other relevant external stakeholdersReview 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.Learn: 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 transparencyThe Team You'll Join Reporting to the Vice President, Regulatory, you'll lead the development of regulatory strategies for the assigned program. publishing function within the Regulatory Department. As the regulatory strategy lead on this diverse team, you'll work collaboratively with fellow team members and stakeholders from cross-functional teams to support clinical programs (IND-enabling and clinical-stage assets) in alignment with Recursion's regulatory strategy.The Experience You'll NeedA minimum of 10 years in the pharmaceutical industry with a minimum of 8 years in Global Regulatory Affairs, experience with major Health Authority (US FDA, Health Canada, UK MHRA and EMA) is mandatoryMinimum of 6 years experience with regulatory submissions (e.g. Investigational New Drug Applications(INDs), New Drug Applications (NDANDSMAA), Clinical, CMC, post marketing measures, Paediatric Investigation Plans (PIP)(PSP) and Orphan Drug Designation (ODD), Breakthrough Designation (BTD), EU PRIME activities) are mandatory. Strong understanding of regulatory strategy (Clinical, CMC) 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 teamsWorking Location:This position is ideally based at one of our offices located in New York City or Salt Lake City. Please note that we are a hybrid environment and ask that employees spend 50% of their time in the office.#LI-CP1The Values That We Hope You Share:We Care: We care about our drug candidates, our Recursionauts, their families, each other, our communities, the patients we aim to serve and their loved ones. We also care about our work.We Learn: Learning from the diverse perspectives of our fellow Recursionauts, and from failure, is an essential part of how we make progress.We Deliver: We are unapologetic that our expectations for delivery are extraordinarily high. There is urgency to our existence: we sprint at maximum engagement, making time and space to recover. Act Boldly with Integrity: No company changes the world or reinvents an industry without being bold. It must be balanced; not by timidity, but by doing the right thing even when no one is looking.We are One Recursion: We operate with a 'company first, team second' mentality. Our success comes from working as one interdisciplinary team.Recursion spends time and energy connecting every aspect of work to these values. They aren't static, but regularly discussed and questioned because we make decisions rooted in those values in our day-to-day work. You can read more about our values and how we live them every day here.More About Recursion Recursion is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world's largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale - up to millions of wet lab experiments weekly - and massive computational scale - owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in London, Toronto, Montreal and the San Francisco Bay Area. Learn more at or connect on X (formerly Twitter) and LinkedIn.Recursion is an Equal Opportunity Employer that values diversity and inclusion. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.Recursion welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.

Created: 2025-03-09