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Recursion Pharmaceuticals is seeking a Director of Regulatory Affairs to lead global regulatory strategy and oversight for assigned drug development programs. Reporting to the Vice President of Regulatory, you will play a critical role in supporting regulatory processes, identifying and managing regulatory risks, and collaborating with cross-functional teams across clinical, commercial, and medical affairs to ensure successful product registration and lifecycle management.
Key responsibilities include: building and maintaining relationships across global teams to manage regulatory strategy and activities across all applicable jurisdictions (EU, US, UK); managing complex, time-sensitive projects simultaneously while assessing immediate and long-term program risks; creating and implementing regulatory procedures and strategies to support clinical trial applications, marketing authorization applications, orphan drug designations, pediatric submissions, and other regulatory submissions; serving as the primary point of contact with health authorities and external stakeholders; reviewing and interpreting regulatory guidelines to assess impact and communicate findings; and staying current with evolving regulations, guidance documents, and scientific literature.
You will work with Clinical Study Teams to deliver business objectives for assigned products at all development stages, from IND-enabling through post-approval. The role requires strong cross-functional collaboration, sound judgment in risk assessment, and the ability to think creatively about how emerging technologies can shape regulatory science and accelerate paths to patients.
Required qualifications: minimum 10 years in the pharmaceutical industry with at least 8 years in global regulatory affairs; demonstrated experience with major health authorities (US FDA, Health Canada, UK MHRA, EMA); minimum 8 years of hands-on experience with regulatory submissions including INDs, NDAs/MAAs, post-marketing measures, pediatric investigation plans, orphan drug designations, and breakthrough designations; strong understanding of regulatory strategy and operational implementation; and excellent management, interpersonal, communication, negotiation, and problem-solving skills. Experience in oncology, rare disease, and immunology/infectious disease is valued.
