Compliance Officer

6 days ago


New Bedford, Massachusetts, United States Lantheus Full time

Lantheus is a leading innovator in the medical imaging industry, with a rich history of pioneering new technologies and solutions. Our company is headquartered in the United States, with offices in North America, Europe, and Asia.

We are a dynamic and entrepreneurial organization, dedicated to empowering clinicians to find, fight, and follow disease. Our purpose and values guide our behaviors in all interactions, creating a dynamic environment that contributes to our success.

Every employee is crucial to our success, and 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.

Key Responsibilities:

  • Develop, maintain, and implement global product labeling components, ensuring high-quality and compliant labeling documents.
  • Provide leadership to the Regulatory labeling team in the creation and maintenance of global product labeling components.
  • Collaborate with other functional work teams, including Supply Chain, Operations, Commercial, and Clinical, providing regulatory guidance to aid in the preparation and submission of global product labeling materials.
  • Review labeling for compliance with applicable region's labeling regulations and requirements, making recommendations to ensure compliance.
  • Oversee activities within the labeling management system.
  • Serve as the key contact for global product labeling documentation materials and questions, ensuring they are completed in accordance with regulations.
  • Support metrics to track the effectiveness of the labeling review process and provide recommendations for process improvements.
  • Employ a current understanding of our product offerings and the industry to impart beneficial, operational regulatory advice to a range of internal functional partners.
  • Maintain current knowledge of and ensure 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.
  • Actively promote safety rules and awareness, demonstrating good safety practices, including appropriate use of protective equipment.
  • 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 with 4-6 years of regulatory experience in a pharmaceutical environment.
  • Minimum 2 years' experience in Regulatory Labeling.
  • Knowledge of advertising, labeling, and promotion regulations and guidance for pharmaceuticals and devices.
  • Non-routine travel based on business need.

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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