Director of Regulatory Affairs

Job Summary

To support global regulatory strategy, the remote-friendly Director of Regulatory Affairs will manage regulatory processes, oversee documentation quality, and collaborate with cross-functional teams to ensure successful product registration and lifecycle management.

Key responsibilities

• Build and maintain relationships across teams to manage regulatory strategy and activities for product development in various jurisdictions
• Manage complex regulatory issues and coordinate multiple projects while assessing risks related to program impact
• Create and implement procedures for regulatory execution and support program leads with regulatory submissions and compliance

Required qualifications

• A minimum of 10 years in the pharmaceutical industry, with at least 8 years in Global Regulatory Affairs
• Experience with major Health Authorities (e.g., US FDA, EMA) and regulatory submissions (e.g., INDs, NDAs)
• Strong understanding of regulatory strategy and operational implementation
• Proficiency in managing cross-functional and global team dynamics
• Experience in oncology, rare disease, and immunology is preferred