Director, Regulatory Affairs

1 hour, 29 minutes ago
Full-time
Executive
Legal
Recursion

Recursion

Recursion specializes in leveraging artificial intelligence to revolutionize drug discovery by decoding biological data and utilizing advanced imaging techniques to train AI models for understanding complex relationships between genes and compounds.

Pharmaceuticals
251-1K
Founded 2013
$665M raised

Description

  • Lead regulatory strategy and activities across applicable jurisdictions, including the US, EU, and UK, throughout development and post-approval.
  • Participate in global product team and clinical study team meetings, providing regulatory guidance and managing day-to-day activities.
  • Assess regulatory risks, manage complex issues, and coordinate multiple time-sensitive projects.
  • Develop and implement regulatory procedures and support submissions such as clinical trial applications, marketing authorization applications, pediatric submissions, and orphan drug applications.
  • Collaborate with Clinical, Commercial, Medical Affairs, Strategic Operations, toxicology, pharmacology, and clinical development teams.
  • Serve as a point of contact and lead interactions with health authorities and external stakeholders.
  • Review regulatory guidelines, assess their impact, and communicate relevant requirements across the organization.
  • Review regulatory documents for consistency and quality and identify gaps against regulatory strategies.
  • Maintain current knowledge of regulations and regulatory science, particularly emerging technology-enabled drug development approaches.

Requirements

  • At least 10 years of pharmaceutical industry experience, including at least 8 years in Global Regulatory Affairs.
  • Experience with major health authorities, including US FDA, Health Canada, UK MHRA, and EMA.
  • At least 8 years of experience with regulatory submissions, including INDs, NDAs/NDS/MAAs, post-marketing measures, PIPs/PSPs, ODD, BTD, and EU PRIME activities.
  • Strong understanding of global regulatory strategy and operational implementation.
  • Experience working cross-functionally and on global teams.
  • Strong management, interpersonal, communication, negotiation, and problem-solving skills.
  • Experience in oncology, rare disease, or immunology and inflammation is preferred.

Benefits

  • Remote-friendly work arrangement with most work conducted from home.
  • Estimated annual base salary of £111,100–£141,800.
  • Annual bonus eligibility.
  • Equity compensation.
  • Comprehensive benefits package.
  • Occasional travel opportunities or expectations to the London office.

Interested in this position?

Apply directly on the company website

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