Associate Director, Clinical Regulatory

Role: Associate Director, Clinical Regulatory at a biopharma focused on innovative molecular imaging platforms, responsible for managing global clinical trial applications (CTAs) and ensuring regulatory compliance ex-US. Responsibilities include developing and executing international CTA strategies, overseeing submission processes across multiple regions including Europe, Asia Pacific, and Latin America, and maintaining lifecycle management. The role involves collaborating with clinical operations, CMC, and quality teams to integrate regulatory considerations, acting as liaison with regulatory agencies, supervising quality systems compliance with GCP and GDPR, and proactively managing regulatory risks. Requirements: 10+ years of relevant experience (or 8+ with postgraduate degree), deep knowledge of international regulations such as EU-CTR, ICH, and country-specific standards, proficiency with submission platforms like CTIS or IRIS, and strong project management and communication skills. Preferred qualifications include experience with Veeva, Microsoft Office, and electronic regulatory systems. High-value specifics: focus on ex-US regulatory landscapes, global clinical trials, and compliance with GxP, GCP, GDPR. Work setup requires a minimum of 3 days onsite in Jersey City, NJ, with extensive cross-functional collaboration across clinical and regulatory teams.