Purpose / Summary

Responsible for integrating and applying knowledge of global regulations governing radiopharmaceuticals and diagnostics to ensure compliance and coordinate submissions supporting the Company’s preclinical, clinical development and lND products. Evaluates proposed regulations and advises on impact of such regulations on the company; provides advice and counsel on cross functional technical teams to support manufacturing, testing and global distribution activities for Lantheus development portfolio in a highly energized and collaborative environment.

Essential Functions

• Collaborates with other functional work teams e.g., Preclinical, Clinical, Medical Affairs, Manufacturing and Quality Control, providing regulatory guidance to aid in preparing, reviewing, and approving of regulatory IND submissions materials.
• Manages a range of concurrent regulatory projects, and issues, and respond timely to ensure regulatory submissions are reviewed and approved to meet project target dates.
• Provides a current knowledge of regulatory perspectives and considerations to a range of internal functional work teams.
• Acts as regulatory specialist on development project cross-functional team processes. Serve on a range of cross-functional team processes, providing current regulatory perspectives and considerations. Make recommendations aimed at ensuring compliance.
• Maintains responsibility for the regulatory strategy related to maintenance of IND applications and pre-market therapeutic and diagnostic imaging product offerings.
• Closely collaborates with Technical Operations team members, and other key partners both internal and external to the company, aimed at ensuring regulatory documentation meets project target dates.
• Executes compilation of IND regulatory submissions including annual reports, amendments and coordinate responses to health authority questions and comments.
• Reviews study protocols, statistical analysis plans, updates to investigation brochures and other documentation for regulatory compliance; including FDA IR and responses, annual reports, and any other Study related documentation.
• With supervision, may interact directly with the FDA and with other Health Authorities through local regulatory managers, responding to technical regulatory questions related to clinical strategy.
• Serves as the primary contact for IND documentation materials and questions, ensuring they are completed in accordance with regulations, and collaborate on final versions.
• Has a good understanding of the development products and Health Authority guidance to impart beneficial, operational regulatory advice to a range of internal functional partners.

Associate Director Regulatory

• Maintains current knowledge of, and ensure all work activities are conducted in compliance with the full range of related internal and external systems, technology, regulatory requirements and related policies and procedures.
• Actively maintains and demonstrates the Lantheus values.
• Ensure rapid and effective development and review of regulatory documents to be submitted to the FDA and international regulatory agencies.

Typical Minimum Skills and Experience and Education

• BS/BA degree in a scientific discipline with a minimum of 5-7+ years of experience in a pharmaceutical industry with a focus on the regulatory perspective for the clinical aspects, or equivalent.

Other Requirements

• Non-routine travel based on business need.