Senior Director, Quality & CMC Regulatory Strategy

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.
• Possess strong communication skills to 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.

Compensation

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

Benefits

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

Contact Information

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.