Senior Director of Quality

Piper Companies is seeking a Senior Director, Quality & CMC Regulatory Strategy to join a leading regulatory consulting and drug development services organization. The Senior Director, Quality & CMC Regulatory Strategy will provide strategic CMC and quality regulatory guidance to biotechnology and pharmaceutical clients, supporting products from early development through commercialization and lifecycle management.

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 9/4/26. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: regulatory affairs, CMC, chemistry manufacturing and controls, quality assurance, FDA regulations, biotechnology, pharmaceutical development, biologics, small molecules, advanced therapies, regulatory strategy, IND submissions, global submissions, lifecycle management, GMP, regulatory compliance, manufacturing operations, health authority interactions, quality systems, post-marketing submissions, client management, risk assessment, consulting, drug development, regulatory leadership, commercialization.

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