Associate Director, Regulatory Affairs

Role: Associate Director of Regulatory Affairs supporting global clinical programs in oncology, primarily focused on immunotherapy agent ivonescimab across multiple Phase 3 studies in NSCLC and CRC. Responsibilities: develop and execute regulatory strategies, manage IND/CTA submissions, oversee regulatory queries and agency interactions, prepare dossiers for BLA/MAA filings, coordinate health authority meetings, and ensure compliance with global regulatory standards. Qualifications: BA/BS in Biological Sciences or related field; 5+ years in biotech/pharma regulatory affairs; strong knowledge of FDA and international regulations; experience with clinical trial submissions, agency negotiations, and cross-functional collaboration. Preferred skills include experience in lung and colorectal cancer indications, Chinese language skills, and prior global regulatory experience including with CROs and international agencies. High-Value: Oncology (NSCLC, CRC), Phase 3, IND/CTA and BLA/MAA filings, global regulatory strategy, health authority engagement, biologics development, and cross-functional study support. Work setup involves leading regulatory activities across multiple global studies, with potential for cross-coverage and departmental initiatives.