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Eikon Therapeutics, a biopharmaceutical company founded on Nobel Prize-winning innovations, is seeking an experienced Associate Director of Clinical Regulatory to lead regulatory and compliance efforts for clinical trial applications (CTAs) globally. This is a director-level role managing regulatory strategy, international submissions, and cross-functional collaboration.
Key Responsibilities:
- Develop and execute comprehensive global CTA submission strategies supporting clinical trial initiations outside the US, aligned with company strategic objectives
- Advise cross-functional teams on regulatory responses to health authority questions and compliance requirements
- Maintain expertise in evolving ex-US regulations, including EU-CTR (Regulation EU No 536/2014), ICH guidelines, and country-specific requirements
- Ensure company activities and products adhere to all applicable regulatory requirements
- Prepare, review, and coordinate submission of regulatory documents and packages to European and other international competent authorities
- Manage maintenance of applications submitted to regulatory agencies in support of study initiation
- Supervise quality assurance processes and address regulatory risks associated with development programs
- Foster cross-functional collaboration and liaison with regulatory agencies
- Thrive in a fast-paced, fluid biotech environment requiring strong project management, analytical skills, attention to detail, and problem-solving abilities
The role requires a minimum of 3 days per week onsite in Jersey City, with flexibility for additional presence as business needs require. This position is embedded within the Regulatory Affairs function and serves as a member of program teams, indicating leadership and strategic influence across multiple clinical programs.
