Senior Director of Quality - 173874

Responsibilities: of the Senior Director, Quality & CMC Regulatory Strategy include: · Lead global CMC regulatory strategies for development, registration, and post-approval programs. · Serve as a trusted advisor to clients on regulatory pathways, submission planning, and health authority interactions. · Oversee the preparation and review of INDs, amendments, global filings, and lifecycle management submissions. · Collaborate with quality, manufacturing, and development teams to ensure regulatory compliance and execution. · Mentor regulatory professionals while supporting client engagement and business growth initiatives. Qualifications: for the Senior Director, Quality & CMC Regulatory Strategy include: · Bachelor's degree in a scientific discipline required; advanced degree preferred. · 15+ years of experience in Regulatory Affairs, CMC, Quality, biotechnology, pharmaceuticals, or a related field. · Extensive knowledge of FDA regulations, global regulatory requirements, and CMC submission strategies. · Experience supporting biologics, small molecules, and novel therapeutic platforms across the product lifecycle. · Proven leadership experience managing regulatory teams and serving as a client-facing strategic advisor. Compensation: for the Senior Director, Quality & CMC Regulatory Strategy: · Salary Range: $250,000 - $290,000 · Comprehensive Benefits: Medical, Dental, Vision, Paid Time Off, 401(k), and additional company-sponsored benefits. This job opens for applications on 9/25/26. Applications for this job will be accepted for at least 30 days from the posting date.