Senior Director, Regulatory CMC

📋 Description

• Develop and execute integrated regulatory strategies for small-molecule programs, supporting
• Lead regulatory CMC activities for advanced development programs, including NDA-enabling work
• Provide strategic guidance across drug substance, drug product, analytical development
• Serve as the Regulatory CMC subject matter expert on program teams, aligning CMC development plans
• Lead the preparation, review, and approval of CMC documentation for global regulatory submissions
• Provide expert input into regulatory interactions, interpret agency feedback, and develop

🎯 Requirements

• A master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline is
• At least 12 years of pharmaceutical industry experience, including a minimum of five years in
• Recent, direct experience leading Regulatory CMC activities for late-stage development programs
• Demonstrated experience authoring, reviewing, and managing CMC content for regulatory filings
• Proven ability to support regulatory interactions, prepare responses to agency questions, interpret
• Strong understanding of drug substance and drug product development, analytical methods

🎁 Benefits

• Annual salary range of $175,500–$283,800, depending on qualifications, experience, skills, and
• Eligibility for a company bonus based partly on organizational and individual performance.
• Access to a company-sponsored 401(k) plan and pension benefits, subject to applicable eligibility
• Medical, dental, vision, and prescription drug benefits for eligible employees.
• Access to eligible healthcare and dependent-care spending programs.
• Life insurance and death benefits, along with other applicable employee protection benefits.