Senior Director, Regulatory Affairs CMC

Position Summary

Senior Director, Regulatory Affairs CMC providing strategic and operational leadership to ensure effectiveness of the Regulatory Affairs CMC team across the organization. Responsible for all CMC-related submissions, including strategic planning, execution, and quality/accuracy of supporting documents within agreed timelines. Interprets and discusses CMC data with cross-functional teams and Health Authorities.

Job Functions/Responsibilities

• Oversee development and implementation of regulatory CMC strategies for market applications, post-marketing CMC commitments, and global development programs.
• Lead regulatory CMC strategy for assigned projects and ensure execution of those strategies.
• Develop regulatory positions for portfolio assets by incorporating corporate planning, business objectives, and current regulatory requirements into submission planning.
• Ensure team effectiveness in developing submissions and partnering across functions.
• Identify regulatory challenges/risks, propose solutions, lead risk assessments on regulatory CMC topics, and oversee change controls.
• Partner with internal/external stakeholders and manage relationships.
• Ensure CMC dossiers meet ICH format/content requirements and local country requirements.
• Analyze complex issues and apply CMC-based judgment.
• Support regulatory submissions (NDA/MAA, etc.), briefing packages, response documents, and annual updates (e.g., IB, NDA ARs, IND ARs).
• Lead CMC discussions with Health Authorities for small molecules, biologics, and orphan/breakthrough programs.
• Manage direct reports and mentor junior professionals.

Qualifications

• 12+ years of relevant experience in Regulatory Affairs CMC.
• Drug development experience across market (NDA/sNDA/MAA/variations), investigational (IND/CTA), and commercial lifecycle.
• Advanced degree in relevant scientific discipline required (PhD in chemistry or related field preferred).
• Experience in small molecules and biologics regulatory CMC activities from late-stage development through commercialization.
• Combination product experience/knowledge preferred.
• Successful submissions to FDA and/or other Health Authorities (including EMA); Japan/China exposure a plus; other regions a plus.
• Ability to apply scientific principles to assess regulatory issues, analyze data, and draw conclusions.
• Excellent written/verbal communication and ability to partner/influence.
• Strong people management and mentorship skills.
• Excellent planning/organization; ability to manage multiple projects with tight timelines.
• Comfortable in fast-paced small-company environment; adjusts to changing priorities.

Work Environment

• Travel domestically and internationally required (anticipated 5-10%).