Senior Director, Quality & CMC Regulatory Strategy - 174363

About the role

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

• 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

• 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.

Pay

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

Benefits

• Medical
• Dental
• Vision
• PTO
• 401(k)
• additional company-sponsored benefits