Director, Regulatory Affairs, Advertising and Promotion

Lantheus; Bedford (MA); Hybrid; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Director of Regulatory Affairs to lead compliance in advertising and promotions. This pivotal role involves collaborating with various departments to ensure promotional materials align with FDA regulations. The ideal candidate will have extensive experience in regulatory affairs, particularly in advertising and promotion, and will be instrumental in shaping strategies that mitigate regulatory risks. Join a dynamic team that values innovation and respects the critical nature of health in every decision made. This is an opportunity to make a significant impact in a company committed to enhancing patient care.

Qualifications

• 10+ years of experience in regulatory affairs in the pharmaceutical industry.
• Expert understanding of FDA promotional regulations and evidentiary standards.

Responsibilities

• Lead regulatory review of promotional communications ensuring compliance with FDA.
• Act as a strategic partner to internal stakeholders providing regulatory guidance.

Skills

Regulatory Affairs

FDA Regulations

Communication Skills

Project Management

Negotiation Skills

Education

Bachelor's degree in Life Sciences

Advanced degrees (PharmD, PhD, MS, MBA, JD)

Job description

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 of 3 days per week in Bedford, MA when not travelling.

Summary of role

The Director of Regulatory Affairs, Advertising and Promotions will be responsible for leading the Regulatory Advertising and Promotion activities for the assigned therapeutic area. This role will provide regulatory advertising and promotion oversight of promotional and medical communications of products within their therapeutic area to ensure compliance with the relevant FDA regulations, guidance, and other regulatory requirements. The Director of Regulatory Affairs, Advertising and Promotions will also collaborate with internal stakeholders in commercial, medical affairs and legal to ensure external communications, including but not limited to promotional communications, are compliant and align with Lantheus' strategic commercial, medical, and regulatory objectives.

Key Responsibilities/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 Lantheus products within their therapeutic area, 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 promotion and labeling.
• 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 the Lantheus products within their therapeutic area, on matters related to advertising and promotional materials. Manage interactions with OPDP, including response to regulatory inquiries, requests for of 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 strategic guidance on product development and label development strategies to ensure promotional claims can be supported and align with Lantheus' strategic imperatives .
• 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.

Basic Qualifications

• Bachelor's degree in Life Sciences, or a related field. Advanced degrees (PharmD, PhD, MS, MBA, JD) preferred.
• Minimum of 10+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a minimum of 5 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.

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 [e-mail].

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.