Associate Director/Director/ Sr. Director, Regulatory CMC

Role: Lead Regulatory CMC strategy and operations for biologics, primarily monoclonal antibodies, supporting clinical development through post-approval lifecycle management. Responsibilities: coordinate and oversee global CMC regulatory submissions (INDs, BLAs, DMFs, amendments), author and review CMC sections, respond to agency queries, and ensure compliance with evolving international regulations (FDA, EMA, ICH). Collaborate with internal Quality, Manufacturing, and external partners such as CMOs and consultants. Provide regulatory guidance across product lifecycle, including post-approval changes. Requirements: 5–10 years in Regulatory CMC within biopharma, with strong expertise in biologics (MABS), analytical methods, process development, manufacturing, and quality control. Experience with biologics, combination products, or cell therapies preferred. Knowledge of device/regulatory requirements (21 CFR Part 4, ISO 13485). BS in a scientific/engineering discipline; MS, PhD, or PharmD preferred. Demonstrated success in preparing submissions and managing cross-functional teams. High-value: biologics, monoclonal antibodies, Regulatory CMC, global filings, lifecycle management, device/combination product experience. Work setup: not specified.