Associate Director, Regulatory Affairs (CMC)

Role: Associate Director, Regulatory Affairs CMC, leading development and implementation of CMC regulatory strategies for biopharmaceuticals in the EMEA region. Responsibilities: coordinate regulatory submissions, develop CMC documentation for EMA, MHRA, and other authorities, author CMC sections for IND/IMPD, NDA/MAA, ensure compliance with global regulations, review change control documents, and interpret complex scientific and regulatory requirements. Requirements: Bachelor's degree with 5-7 years in pharmaceutical development/regulatory CMC, with experience in biologics or inhalation products highly desirable; strong knowledge of EU/ICH regulations, GMP environment, and CMC regulatory processes. Preferred: biologics/biopharma experience in EMEA, and understanding of development stages from early to post-approval. Work setup: fully remote with occasional travel; minimal travel expected.