Manager, Regulatory Affairs

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

Provide operational regulatory expertise and direction to Lantheus commercial functions related to advertising and promotional materials.

Key Responsibilities/Essential Functions

• Serves on the Promotional Review Committee. Act as key member of Medical Legal and Regulatory (MLR) Committee with other internal functional organizations, e.g., Marketing, Medical Affairs, and Legal.
• Collaborates with other MLR members, providing regulatory guidance to aid in preparation of promotional materials, and reviewing and approving materials for commercial use.
• Consults with Marketing in the preparation of advertising and promotional materials to ensure regulatory requirements are met. Collaborates with other R&D and commercial functions on cross-functional team processes, providing current regulatory perspectives and considerations.
• Reviews labeling, advertising and promotional materials for compliance with FDA regulations. Makes recommendations aimed at ensuring compliance.
• May serve as a primary contact with The Office of Prescription Drug Promotion (OPDP). Submits promotional materials to OPDP in accordance with regulations and collaborates on final versions.
• Supports metrics to track the effectiveness of the promotional review process and provides recommendations as necessary for process improvements.
• Employs a current understanding of our product offerings and the industry to impart beneficial, operational regulatory advice to a range of internal functional partners.
• Maintains current knowledge of and ensures all work activities are conducted in compliance with the full range of related internal and external systems, technology, regulatory requirements and related policies and procedures.
• Offers creative solutions and strategies, including risk mitigation strategies.
• Evaluates regulatory risks and makes recommendations relative to the promotional strategy.

Basic Qualifications

• Bachelor’s degree with 6+ years regulatory experience in a pharmaceutical environment.
• Minimum 2 years’ experience in Regulatory Advertising and Promotion
• Knowledge of advertising, labeling, and promotion regulations and guidance for pharmaceuticals and devices.
• Non-routine travel based on business need.

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

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