Director Regulatory CMC

Director, Regulatory Affairs - CMC (Individual Contributor)
Location: Flexible (U.S. based only, remote or hybrid options available)
Employment Type: Full-time

Summary:
A growing biopharmaceutical company is seeking a Director, Regulatory Affairs - CMC to lead global regulatory CMC activities for late-stage and commercial products. This individual will act as a subject matter expert and strategic advisor across manufacturing changes, lifecycle management, and global agency engagement.

Key Responsibilities:

• Develop and execute global CMC regulatory strategies for assigned products across clinical development, marketing applications, and post-approval lifecycle management.
• Act as the regulatory lead on cross-functional CMC and submission teams.
• Drive the preparation, authoring, and review of CMC components of global regulatory submissions (e.g., INDs, IMPDs, NDAs, MAAs, amendments, annual reports).
• Lead regulatory interactions with global health authorities (FDA, EMA, PMDA, etc.), including meeting preparation, briefing document development, and strategy alignment.
• Provide proactive regulatory guidance to internal stakeholders regarding post-marketing manufacturing changes, comparability protocols, and global CMC compliance requirements.
• Stay current with evolving global CMC regulations and proactively assess impact to programs.
• Support responses to regulatory inspections and audits as needed.

Qualifications:

• Bachelor's degree in a relevant scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences); advanced degree preferred.
• Minimum 10 years of experience in Regulatory Affairs with a specific focus on CMC.
• Proven experience with NDA submissions and post-marketing regulatory support, particularly for manufacturing changes and global lifecycle management.
• Strong understanding of global regulatory requirements and experience working with health authorities in the U.S., EU, and Japan.
• Demonstrated success in leading CMC strategy across multiple phases of product development.
• Strong communication skills, ability to influence cross-functional partners, and comfort operating in a highly matrixed, fast-paced environment.
• Comfortable working independently as an individual contributor with a strategic mindset and hands-on approach.

This role is ideal for a seasoned CMC regulatory expert who enjoys rolling up their sleeves and influencing global strategy without direct reports.