Sr. Director, Regulatory Affairs

Role: Senior Director of Regulatory Affairs leading strategy, compliance, and submissions for biopharmaceutical products at Eikon Therapeutics. Responsibilities: develop regulatory strategies supporting product development and market approval, ensure adherence to FDA and international regulations, oversee IND/ NDA/ MAA submissions, collaborate with R&D, Quality Assurance, and Clinical teams, supervise quality systems compliance, and manage regulatory risk assessments. Requirements: postgraduate degree with 12+ years or bachelor's with 15+ years relevant experience; deep knowledge of FDA and global regulations; strong communication, negotiation, and project management skills; proven cross-functional collaboration and problem-solving abilities. HighValue: biopharma, regulatory strategy, IND/ NDA/ MAA submissions, GxP compliance, cross-functional collaboration, fast-paced high-growth environment. WorkSetup: minimum 3 days/week onsite in Jersey City, NJ, with flexibility needed for business needs.