Senior Director, Quality & CMC Regulatory Strategy

Piper Companies is seeking a Senior Director, Quality & CMC Regulatory Strategy to join a leading global organization specializing in regulatory consulting and clinical development services for a remote permanent position. The Senior Director, Quality & CMC Regulatory Strategy will serve as a senior advisor to biotechnology and pharmaceutical clients, leading complex CMC regulatory initiatives, guiding global submission strategies, and driving successful product development programs across multiple therapeutic modalities.

Responsibilities of the Senior Director, Quality & CMC Regulatory Strategy include:

· Lead the development and execution of global CMC regulatory roadmaps for biotechnology and pharmaceutical clients across various stages of product development.

· Act as a primary consultant and trusted client advisor, providing strategic direction for regulatory agency interactions, submission planning, and risk management initiatives.

· Oversee the preparation and review of regulatory documentation, including IND submissions, lifecycle management activities, supplements, and international filings.

· Provide leadership and mentorship to regulatory professionals while fostering technical excellence and collaboration across project teams.

· Partner with quality, manufacturing, and development stakeholders to ensure regulatory compliance and alignment with evolving global health authority expectations.

Qualifications for the Senior Director, Quality & CMC Regulatory Strategy include:

· Bachelor's degree in a scientific discipline required; advanced scientific or regulatory degree preferred.

· 15+ years of experience in Regulatory Affairs, CMC, Quality, or related pharmaceutical and biotechnology fields.

· Prior experience within a CRO, regulatory consulting organization, or pharmaceutical/biotechnology company.

· Deep expertise in CMC regulatory strategy, FDA regulations, and global regulatory requirements.

· Proven leadership experience managing senior-level regulatory professionals and client-facing programs.

· Strong knowledge of biologics, small molecules, advanced therapies, and product lifecycle management from early development through commercialization.

Compensation for the Senior Director, Quality & CMC Regulatory Strategy:

Salary Range: $260,000-$300,000/year (USD)

Comprehensive Benefits: Medical, Dental, Vision, PTO, 401(k), and additional company-sponsored benefits.

This job opens for applications on 8/27/26. Applications for this job will be accepted for at least 30 days from the posting date.

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

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