Senior Director, Regulatory Affairs Lead

4 weeks ago


New Bedford, Massachusetts, United States Lantheus Full time

Lantheus is a leading company in the field of medical imaging, with a strong presence in Bedford, Massachusetts, and offices in New Jersey, Canada, and Sweden. We have a rich history of innovation, with over 60 years of experience in pioneering medical imaging solutions.

As a Senior Director, Regulatory Affairs, you will play a critical role in our continued success. You will lead a team of direct reports and manage other people leaders, hiring, developing, and retaining diverse top talent. You will set clear and elevating goals for the team and individual direct reports, coaching them on their performance, development, and career interests.

Key responsibilities include collaborating with colleagues in Commercial, Medical Affairs, Legal, Compliance, and other expertise areas in the creation of promotional and disease awareness communications, field training materials, and materials used in scientific exchange. You will also act as Lantheus liaison to the FDA's Office of Prescription Drug Promotion (OPDP) for assigned products, preparing correspondence for advisory comment submissions and conducting negotiations.

You will monitor new or revised legislation, regulations, guidance documents, industry standards, and enforcement actions related to promotional communications, disease awareness, scientific exchange, and human subject protection, analyzing and communicating their relevance. You will work closely with Regulatory Operations in making timely submissions of promotional materials to FDA.

Additional responsibilities include overseeing and guiding the preparation and maintenance of regulatory labeling for multiple products across therapeutic areas, representing or overseeing other team members representing RA Labeling on RA Project Teams, at cross-functional submission team meetings, and on joint labeling/safety meetings with partner companies.

You will oversee and guide or lead review/approval of U.S. labeling in Structured Product Labeling (SPL) format, artwork requests, archiving labeling documents, and updating label histories. You will manage complex labeling negotiations with regulatory authorities and train other RA Labeling colleagues or cross-functional team members in various matters relating to RA labeling.

Requirements include a PharmD/PhD with 8+ years' relevant experience, MA/MS/MBA with 12+ years' relevant experience, or BA/BS with 14+ years' relevant experience. You must have extensive experience leading development of regulatory labeling or related strategies, as well as Ad/Promo strategy and leadership. Experience in NDA/BLA labeling and labeling negotiations is also required.

We are an equal employment opportunity employer and are committed to diversity and inclusion. We will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. If you require an accommodation in connection with the hiring process and/or to perform the essential functions of the position, please contact the Lantheus Talent Acquisition team.



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