Director, Regulatory Affairs - Strategy

Role Summary

The Director of Regulatory Affairs Strategy is responsible for integrating and applying knowledge of global regulations governing radiopharmaceutical drug development for assigned programs to advance the development and commercialization of the Company’s portfolio of assets. The Director will have responsibility for leading regulatory strategies for assigned programs.

Responsibilities

• Work collaboratively on a range of cross-functional project teams, providing current regulatory perspectives and considerations. Make recommendations to progress programs while ensuring compliance with regulations and applicable guidance.
• Serve as the Regulatory lead on asset teams that are driving development and ultimate approval of company assets. This includes regulatory strategy development, regulatory agency engagements, submission plan development and execution.
• Drive and manage the submission plans and authoring of content for assigned programs for IND/CTA/IMPD/NDA applications, including meeting requests, briefing documents, etc.
• Manage a range of concurrent regulatory projects and issues and respond timely to ensure due dates are met.
• Closely collaborate with key partners both internal and external to the company, aimed at ensuring regulatory documentation meets requirements and due dates.
• Executes on compilation of regulatory submissions including annual reports, and necessary amendments and supplements.
• Reviews Technical Operations, and Development documentation intended to support IND/CTA/IMPD/NDA applications for regulatory compliance.
• Coordinates responses to health authority agencies request for information and/or questions in a timely manner.
• Interacts directly with the FDA and with other Health Authorities responding to technical regulatory questions related to clinical strategy.
• Serves as the primary contact for IND/CTA/IMPD/NDA filing materials and questions for assigned programs, ensuring they are completed in accordance with regulations.
• Performs literature searches, prepares reports and assembles documentation to support project teams as required.
• Strong organizational and planning skills, and ability to communicate effectively and efficiently to multiple audiences.

Qualifications

• BS/BA degree in a scientific discipline. MS/PhD preferred.
• Minimum of 7 to 10 years of experience in the pharmaceutical industry including leading programs through regulatory submissions. Experience with radiopharmaceuticals preferred but not required.
• Experience with 21 CFR 212 (i.e. PET Radiopharmaceutical Regulations) is a plus
• Less than 10% travel based on business need

Skills

• Regulatory strategy development and execution for IND/CTA/IMPD/NDA filings
• Regulatory agency engagement and correspondence
• Technical documentation review for regulatory compliance
• Cross-functional collaboration and program leadership
• Literature review and documentation preparation

Education

• BS/BA in a scientific discipline; MS/PhD preferred

Additional Requirements

• Remote position; eligible to work for any employer within the United States