Regulatory Affairs Associate Director

Job Summary

To lead regulatory strategy and submissions, the full-time salaried Regulatory Affairs Associate Director will manage regulatory processes and ensure compliance for product development in an onsite environment.

Key responsibilities

• Develop and implement regulatory strategies for product submissions and approvals
• Coordinate with cross-functional teams to ensure compliance with regulatory requirements
• Prepare and review regulatory documents and submissions to health authorities

Required qualifications

• Advanced degree in life sciences, regulatory affairs, or a related field
• Significant experience in regulatory affairs within the pharmaceutical or biotechnology industry
• Proven track record of successful regulatory submissions and interactions with regulatory agencies
• Strong understanding of global regulatory requirements and guidelines
• Experience managing teams and leading projects in a regulatory environment