Director, Regulatory Affairs - Strategy

Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

This position is site-based and requires a presence on-site in Bedford, MA three days per week.

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.

Essential Functions

• 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.

Typical Minimum Skills and Experience and Education

• 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

Core Values

The ideal candidate will embody Lantheus core values:

• Let people be their best
• Respect one another and act as one
• Learn, adapt, and win
• Know someone's health is in our hands
• Own the solution and make it happen

Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.