Associate Director, Regulatory CMC - Remote

Overview

We are seeking an Associate Director in Regulatory, CMC who can independently lead, contribute and execute on CMC regulatory activities in support of Deciphera’s studies across all stages of clinical drug development.

In Short

• Collaborate with CMC cross-functional team members to plan, write and review CMC sections of pertinent regulatory submissions.
• Provide regulatory guidance to cross-functional team members on required content of Module 2/Module 3.
• Review documentation in support of CMC and QA activities for drug development programs.
• Review and assess proposed CMC changes during drug development for regulatory impact.
• Communicate with regulatory Health Authorities on project-related matters.
• Provide insight and guidance on implementation of current regulations.
• Review industry guidance and pharmacopoeia updates.

Requirements

• B.S. in a scientific discipline required, advanced degree a plus.
• At least 8 years pharmaceutical industry experience in CMC Regulatory Affairs.
• Demonstrated leadership and track record of regulatory submissions.
• Experience in preparing high quality CMC regulatory submissions.
• Strong knowledge of current Good Manufacturing Practices.
• Knowledge of eCTD elements and structure.
• Previous experience leading/supporting interactions with health authorities.
• Proven ability to manage multiple projects.
• Excellent organizational and communication skills.
• Strong interpersonal skills.

Benefits

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, vision insurance.
• 401(k) retirement plan with company match.
• Generous parental leave and family planning benefits.
• Outstanding culture and opportunities for personal and professional growth.