Advancing breakthrough therapeutics through the purposeful integration of science and engineering. Backed by Lux.
About the role
We are seeking an experienced Director, Regulatory Affairs to support and execute regulatory strategy across our clinical-stage development programs. In this role, you will play a key role in both shaping regulatory strategy and driving hands-on execution across assigned programs.
What they're looking for
- Regulatory Strategy: Contribute to the development and execution of regulatory strategies supporting product development, approval, and commercialization in alignment with company objectives
- Regulatory Compliance: Maintain current knowledge of evolving regulations, guidance, and industry best practices to ensure ongoing compliance across programs
- Submission Management: Lead and/or support the preparation, review, and submission of regulatory documents, including INDs, NDAs, and MAAs, as applicable
- Cross-Functional Collaboration: Work closely with Clinical Development, R&D, Quality, and other stakeholders to integrate regulatory considerations throughout the development lifecycle and drive alignment
- Quality Support: Support regulatory aspects of quality systems, including compliance with GCP and GLP requirements
- Risk Assessment: Identify regulatory risks, assess potential impact, and proactively recommend mitigation strategies
More about this role
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Position
We are seeking an experienced Director, Regulatory Affairs to support and execute regulatory strategy across our clinical-stage development programs. In this role, you will play a key role in both shaping regulatory strategy and driving hands-on execution across assigned programs. You will provide regulatory guidance throughout the development lifecycle, ensure alignment with FDA and international regulatory requirements, and partner closely with cross-functional teams to advance programs in a compliant, efficient, and high-quality manner. This role will report to a Senior Director, Regulatory Affairs, and requires a minimum of 3 days per...
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