Associate Director, Regulatory Affairs (Ad-Promo/Labeling)

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.

Position Overview

Lead the regulatory oversight of our advertising, promotional materials, and product labeling. This role requires a proactive leader who can navigate complex regulatory landscapes, influence cross-functional teams, and ensure compliance with all relevant regulations.

Essential Functions

• Collaborate on the complete lifecycle of product labeling, including commercial and clinical labeling, from initial development through updates and routine maintenance. Ensure all labeling activities meet regulatory standards and align with organizational goals.
• Support the Regulatory Affairs team dedicated to labeling and advertising/promotion, contributing to strategic direction and guidance for all labeling and promotional activities, ensuring regulatory compliance and quality across all stages.
• Assist in the operations of the Promotional Review Committee (PRC), providing input on product labeling and other promotional materials. Work closely with Marketing, Medical Affairs, and Legal to ensure robust regulatory oversight and strategic alignment across all promotional content and labeling efforts.
• Offer expert consultation and guidance on the development, review, and approval of advertising, promotional materials, and labeling. Ensure all materials adhere to FDA regulations, industry standards, and internal policies.
• Conduct thorough reviews of product labeling and promotional content to ensure compliance with FDA guidelines and other regulatory requirements. Develop and implement strategies to address compliance issues and enhance accuracy and effectiveness.
• Act as one of the primary points of contact with the Office of Prescription Drug Promotion (OPDP), managing the submission process of promotional materials and collaborate on the final approval of materials.
• Contribute to mentoring and developing the Regulatory Labeling and Ad/Promo team, fostering a high-performance team environment and ensuring alignment with regulatory requirements and organizational goals.
• Maintain up-to-date knowledge of current regulations, industry trends, and internal systems. Ensure all activities comply with regulatory requirements, internal policies, and industry standards.
• Actively promotes safety rules and awareness. Always demonstrates good safety practices including appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
• Actively demonstrates the Lantheus values of Know someone's health is in our hands, Let people be their best, Respect one another and act as one, Learn, adapt and win, Own the solution and make it happen.
• Offer creative solutions and strategies, including risk mitigation strategies.
• Evaluate regulatory risks and make recommendations relative to the labeling strategy.

Basic Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, or a related field. Advanced degrees or professional certifications in regulatory affairs are preferred.
• Minimum of 8-10 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a strong focus on labeling and promotional materials. Proven leadership experience is highly desirable.
• In-depth knowledge of FDA regulations, industry guidelines, and best practices related to advertising, promotion, and labeling. Excellent communication, negotiation, and project management skills. Ability to influence cross-functional teams and drive strategic initiatives.
• Occasional travel may be required based on business needs.

• This position is preferred to be site-based and would require a presence on-site of 3 days per week in Bedford, MA when not traveling. However, remote candidates may be considered.

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.