Associate Director, Regulatory Affairs, Advertising and Promotion

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. 

Summary

The Associate Director of Regulatory Advertising and Promotions will be responsible for leading the Regulatory Advertising and Promotion activities for the assigned Lantheus product(s). This role will provide regulatory advertising and promotion oversight of promotional and medical communications of assigned product(s) to ensure compliance with the relevant FDA regulations, guidance, and other regulatory requirements. The Associate Director of Regulatory Advertising and Promotions will also support the label development and strategy of the assigned Lantheus product(s).

Essential Functions

• Lead the regulatory review as a member of a multidisciplinary medical, legal and regulatory review team of the promotional and medical communications for the assigned Lantheus product(s) ensuring they comply with FDA regulations, guidance, and company policies.
• Act as a subject matter expert on FDA regulations, guidance, enforcement trends and policy issues relevant to advertising and promotion.

• Serve as a strategic partner to internal stakeholders including Commercial, Medical Affairs, Corporate Communications, Legal and Compliance providing regulatory guidance and perspectives on key business strategies, objectives and tactics.
• Propose creative, effective, and compliant strategies and solutions to challenging promotional concepts that meet business objectives and mitigate regulatory risk. Provide promotional regulatory input on concepts and draft materials to ensure they are aligned to FDA regulations, guidance, and company policies.
• Act as the primary point of contact with the Office of Prescription Drug Promotion (OPDP) for assigned product(s) on matters related to advertising and promotional materials. Manage interactions with OPDP, including response to regulatory inquiries, requests for advisory comments, and as needed discussions with OPDP. Oversee the preparation and timely submission of regulatory documents related to promotional materials, including Form FDA 2253 submissions. 
• Provide product development and label development strategies to ensure promotional claims can be supported.
• Collaborate/advise as needed 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.
• 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.
• Mentor junior members of the Regulatory Advertising and Promotions/ Labeling team and foster their development through sharing knowledge and providing feedback.
• Actively demonstrate 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.

 Basic Qualifications

• Bachelor’s degree in Life Sciences, or a related field. Advanced degrees (PharmD, PhD, MS, MBA, JD) preferred.
• Minimum of 6 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a minimum of 3 years’ experience specific to Regulatory Affairs – Advertising and Promotion.

• Launch experience or experience managing regulatory advertising and promotion filing(s) (e.g., launch advisory comment submission or responses to enforcement letters) highly desirable.
• Ability to understand and interpret clinical trial data. Expert understanding of FDA promotional regulations, product and therapeutic knowledge as well as evidentiary standards required to support product claims.
• Excellent oral and written communication with ability to clearly and concisely articulate the regulatory risk to internal stakeholders.
• Demonstrated history of applying in-depth knowledge of FDA regulations, industry guidelines, and best practices related to advertising, promotion, and labeling into regulatory guidance provided to internal stakeholders.
• Ability to spot issues and offer innovative and compliant solutions guidance to mitigate risks.

• Excellent 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 site-based and requires a presence on-site of 3 days per week in Bedford, MA when not travelling.

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.