Associate Director of Regulatory Affairs

Job Summary

To support a growing regulatory team, the full-time Associate Director of Regulatory Affairs will develop and implement US regulatory strategies, serve as the primary contact with the FDA, and oversee the preparation of regulatory submissions while working remotely.

Key responsibilities:

• Develop and implement robust US regulatory strategies for assigned projects
• Lead interactions with the FDA and prepare company personnel for meetings
• Oversee the preparation of regulatory submission documents, ensuring compliance with requirements

Required qualifications:

• Minimum 8 years of regulatory affairs experience in biopharmaceutical organizations, with 3-5 years in global leadership roles focused on the FDA
• PhD or PharmD preferred
• Thorough understanding of the drug development process, particularly with orphan drugs
• Experience interacting with regulatory authorities and coordinating critical regulatory documents
• Strong organizational and project management skills, with experience in strategic planning and resource allocation