Associate Director of Regulatory Affairs

Job Summary

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

Key Responsibilities

• Lead the development and implementation of regulatory strategy for assigned projects
• Manage regional regulatory activities and represent the Global Regulatory Affairs team in project meetings
• Ensure compliance with regulatory requirements and oversee the preparation of regulatory submissions

Required Qualifications

• Bachelor's degree in a related field required; Master's degree preferred
• Approximately 7 years of experience in the biopharmaceutical or pharmaceutical industry, with at least 4 years in regulatory affairs
• Advanced understanding of FDA and ICH regulations specific to clinical research
• Experience in NDA/MAA/CTD submissions and leading regulatory strategies
• Proven ability to interact with health authorities and lead negotiations