Sr. Director, Regulatory Affairs

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.

We are seeking an experienced Senior Director, Regulatory Affairs, to lead our regulatory strategy and compliance efforts. In this critical role, you will be responsible for ensuring that our biotechnological innovations align with all relevant regulations and standards. You will collaborate with cross-functional teams to guide product development and market entry strategies while maintaining a steadfast commitment to regulatory integrity and transparency.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Jersey City (NJ) office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

The ideal candidate for this role is a seasoned regulatory professional who possesses in-depth knowledge of FDA and international regulatory requirements and guidelines, coupled with exceptional communication, negotiation, and project management skills. Their proven ability to thrive in a collaborative, cross-functional team environment, along with strong analytical skills, attention to detail, effective problem-solving abilities, and adaptability, makes them well-suited for the position. In this role, they will excel in developing and executing regulatory strategies, ensuring compliance, managing submissions, fostering cross-functional collaboration, liaising with regulatory agencies, supervising quality assurance, and addressing regulatory risks associated with projects.

• Regulatory Strategy: Develop and execute comprehensive regulatory strategies that support product development, approval, and commercialization while aligning with the company's strategic objectives.

• Regulatory Compliance: Stay abreast of evolving regulations, guidelines, and industry best practices. Ensure that the company's activities and products adhere to all applicable regulatory requirements.

• Submission Management: Oversee the preparation, review, and submission of regulatory documents, including but not limited to Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).

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