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.

• 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.

• 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.

• biologics, monoclonal antibodies, Regulatory CMC, global filings, lifecycle management, device/combination product experience.

not specified.