Manager, Regulatory Affairs, Labeling

3 months ago

Bedford, United States Lantheus Medical Imaging Inc Full time
Job DescriptionJob Description

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

Responsible for the development, maintenance and implementation of global product labeling components and applying knowledge of global regulations to ensure high quality and compliant labeling documents.

Key Responsibilities/Essential Functions

  • Provides leadership to the Regulatory labeling team in the creation and maintenance of global product labeling components.
  • Collaborates with other functional work teams e.g., Supply Chain, Operations, Commercial and Clinical, providing regulatory guidance to aid in the preparation and submission of global product labeling materials.
  • Reviews labeling for compliance with applicable region’s labeling regulations and requirements. Make recommendations aimed at ensuring compliance.
  • Oversees activities within the labeling management system.
  • Serves as the key contact for global product labeling documentation materials and questions, ensuring they are completed in accordance with regulations.
  • Supports metrics to track the effectiveness of the labeling review process and provide 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 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 promotes safety rules and awareness. Always demonstrates good safety practices including appropriate use of protective equipment. Reports and takes initiative to correct safety and environmental hazards.
  • 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 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:

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.

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