Associate Director, Regulatory Affairs

Role: Associate Director, Regulatory Affairs at a cardiovascular biopharma focusing on muscle biology and cardiac dysfunction. Objectives include developing and executing regulatory strategies, ensuring compliant submissions, and supporting health authority interactions across development stages. Responsibilities encompass preparing INDs, CTAs, amendments, and other regulatory documents; leading regulatory reviews; and contributing to internal process improvements. The position demands close collaboration with cross-functional teams such as clinical, CMC, and safety, with an emphasis on global regulatory requirements (FDA, EMA, ICH). Qualifications: Bachelor's degree in a scientific field, 8+ years in drug development, with at least 5 years in regulatory affairs within biotech/pharma; experience with regulatory submissions and health authority interactions; strong knowledge of GxP and global regulations; excellent communication and organizational skills. Preferred: advanced degree. High-value specifics include support for biologics or small molecules in cardiovascular indications, working within a fast-paced biotech environment, with a focus on international regulatory compliance and lifecycle management.