Regulatory Associate Director

Job Summary

To lead regulatory strategy and submissions, the full-time salaried Regulatory Associate Director will manage the regulatory process for drug development and ensure compliance with health authority requirements.

Key responsibilities

• Develop and implement regulatory strategies for clinical programs
• Prepare and submit regulatory documents to health authorities
• Collaborate with cross-functional teams to ensure compliance and alignment on regulatory matters

Required qualifications

• Advanced degree in life sciences, regulatory affairs, or a related field
• Minimum of 7 years of experience in regulatory affairs within the pharmaceutical industry
• Proven track record of successful regulatory submissions
• Strong knowledge of FDA and EMA regulations and guidelines
• Experience managing teams and projects in a regulatory context