Associate Director, Regulatory Affairs

Job Summary

A company is looking for an Associate Director, Regulatory Affairs Project Management.

Key Responsibilities

• Lead submission planning discussions and manage complex regulatory submissions from preparation to approval
• Create and maintain a Global Submission Plan, coordinating post-initial submission activities
• Track timely delivery of submission components and ensure compliance with global Regulatory Authority regulations

Required Qualifications

• Bachelor's Degree in life sciences or chemistry preferred
• 7+ years of experience in regulatory affairs
• Project management experience in the pharmaceutical industry or regulatory environment
• Regulatory experience from pre-IND through Phases I-IV for FDA, EMA, MHRA, and PMDA
• Hands-on experience with eCTD format submissions and related software