Associate Director Regulatory CMC

Job Summary

A company is looking for an Associate Director, Regulatory CMC.

Key Responsibilities

• Lead the planning, authoring, and approval of regulatory submissions for CMC sections
• Provide in-depth reviews of protocols and documents for CMC Development or Commercial teams
• Manage the preparation and submission of responses to regulatory agencies

Required Qualifications

• BSc/BA with a minimum of eight years of regulatory CMC or related experience
• Demonstrated understanding of drug lifecycle regulations and guidelines
• Experience with electronic Common Technical Document CMC regulatory documents
• Knowledge of FDA, EMA, and ICH guidelines
• Ability to influence and work within multi-disciplinary teams and with external partners