A BDN client is looking for a Senior Director, Technical Regulatory Affairs consultant with 12 or more years of experience within the biologics industry. He/she will be meeting with Pharmaceutical sciences groups/QA to go over plans for site transfer and authoring CMC Sections of Submissions. This individual needs to be hands-on and be able to write and review documents. They must have Biologics, Module 3 CMC Regulatory, and the most important is late phase biologics/early BLA planning experience. Small Molecule experience is a plus. This individual will be responsible for oversight of the client's small molecule and biologic pipeline from development through post-approval support. Either directly or through delegation to staff and in collaboration with project teams, develop and implement global regulatory CMC strategies to secure and maintain market access for product(s) in line with business objectives. This position will manage regulatory staff to support CMC aspects of compounds through all phases of development, post-approval, and life-cycle of a product. This role reports to the SVP of Regulatory Affairs. A BS/MS/Ph.D. (or equivalent) in a scientific discipline with a minimum of 12 years of industry experience, or equivalent based on training and experience is desired.