SENIOR DIRECTOR, REGULATORY AFFAIRS

Company: Lantheus
Location: Bedford
Posted on: September 28, 2024

Job Description:

Description Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, 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. Summary of Role We are seeking an experienced leader with proven management and regulatory expertise s related to advertising/promotional materials and labeling Key Responsibilities/Essential Functions * Leads and manages a team of direct reports and may manage other people leaders. Hires, develops, and retains diverse top talent in the team. Sets clear and elevating goals for the team and individual direct reports. Coaches direct reports on their performance, development, and career interests * Collaborate with colleagues in Commercial, Medical Affairs, Legal, Compliance and other expertise areas in creation of promotional and disease awareness communications, field training materials, and materials and communications used in scientific exchange, for assigned product(s) * Act as Lantheus liaison to the FDA's Office of Prescription Drug Promotion (OPDP) for assigned product(s), including preparing correspondence for advisory comment submissions and conducting negotiations * 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, and analyze and communicate their relevance * Work closely with Regulatory Operations in making timely submissions of promotional materials to FDA * Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across therapeutic areas * Represents or otherwise oversees 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 * Oversees and guides or otherwise leads review/approval of U.S. labeling in Structured Product Labeling (SPL) format, artwork requests, archiving labeling documents, and updating label histories * Manages complex labeling negotiations with regulatory authorities * Trains other RA Labeling colleagues or cross-functional team members in various matters relating to RA labeling Basic Qualifications * PharmD/PhD with 8+ years' relevant experience. * MA/MS/MBA with 12+ years' relevant experience. * BA/BS with 14+ years' relevant experience. * 8+ years' experience in prescription drug labeling. * Extensive experience leading development of regulatory labeling or related strategies as well as Ad/Promo strategy and leadership * Extensive experience in NDA/BLA labeling and labeling negotiations * Extensive experience participating in cross-functional projects and teams * Extensive leadership experience and proven effectiveness, whether through direct people leadership or matrix leadership * Proven track record of successfully managing large scale, complex, time-sensitive projects. * Strong track record of cultivating and maintaining strategic relationships and collaborations both internally and externally * Persona example: This position is site-based and requires a presence on-site three days per week. Other Requirements * Veeva knowledge and experience is a plus * Radiopharmaceutical experience is a plus 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 committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable 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. #LI-HYBRID #LI-HYB

Keywords: Lantheus, Boston , SENIOR DIRECTOR, REGULATORY AFFAIRS, Executive , Bedford, Massachusetts