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Eikon Therapeutics, a biopharmaceutical company founded on Nobel Prize-winning innovations, is seeking a Senior Director of Regulatory Affairs to lead regulatory strategy and compliance efforts. The company's discovery platform uses revolutionary microscopy technology to enable real-time, molecular-resolution measurements of protein movement in living cells, unlocking new classes of drug targets.
In this critical leadership role, you will be responsible for developing and executing comprehensive regulatory strategies that support product development, approval, and commercialization while aligning with company objectives. You will oversee regulatory compliance by staying current with evolving FDA and international regulations, guidelines, and industry best practices, ensuring all company activities and products adhere to applicable requirements.
Key responsibilities include managing the preparation, review, and submission of regulatory documents such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs). You will collaborate closely with R&D, Quality Assurance, Clinical Development, and other cross-functional teams to provide regulatory guidance and ensure seamless integration of regulatory considerations into product development.
You will supervise regulatory aspects of quality systems, including compliance with Good Clinical Practices (GCP) and Good Laboratory Practices, and identify and assess regulatory risks associated with projects, proactively proposing mitigation solutions.
The ideal candidate is a seasoned regulatory professional with in-depth knowledge of FDA and international regulatory requirements, exceptional communication and negotiation skills, and proven ability to thrive in collaborative, cross-functional environments. Strong analytical skills, attention to detail, problem-solving abilities, and adaptability are essential. The role requires a minimum of 3 days per week onsite in Jersey City to support team growth and operational excellence.
