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Regulatory Affairs Manager
2 months ago
Lantheus Medical Imaging Inc., a leader in the medical imaging sector, is dedicated to advancing patient care through innovative diagnostics and therapeutic solutions. With a legacy of over 60 years, we are committed to fostering a collaborative and inclusive workplace where every team member plays a crucial role in our success.
Role Summary
The individual in this role will oversee the development, upkeep, and execution of global product labeling components, utilizing extensive knowledge of international regulations to ensure the production of high-quality and compliant labeling documentation.
Key Responsibilities
- Lead the Regulatory labeling team in the creation and maintenance of comprehensive global product labeling components.
- Collaborate with cross-functional teams, including Supply Chain, Operations, Commercial, and Clinical, to provide regulatory guidance for the preparation and submission of labeling materials.
- Review labeling for adherence to regional regulations and requirements, offering recommendations to ensure compliance.
- Manage activities within the labeling management system effectively.
- Act as the primary contact for global product labeling documentation, ensuring timely completion in accordance with regulatory standards.
- Support metrics to evaluate the effectiveness of the labeling review process and suggest improvements as necessary.
- Utilize a current understanding of our product offerings and industry trends to provide valuable regulatory advice to internal partners.
- Maintain up-to-date knowledge of all relevant internal and external systems, technology, regulatory requirements, and policies.
- Promote safety awareness and adherence to safety practices, including the appropriate use of protective equipment.
- Propose innovative solutions and strategies, including risk mitigation approaches.
- Assess regulatory risks and provide recommendations concerning labeling strategies.
Qualifications
- Bachelor's degree with 4-6 years of regulatory experience in the pharmaceutical industry.
- A minimum of 2 years of experience specifically in Regulatory Labeling.
- Familiarity with advertising, labeling, and promotional regulations for pharmaceuticals and medical devices.
- Willingness to travel as needed for business purposes.
Core Values
The ideal candidate will exemplify Lantheus' core values:
- Empower individuals to reach their full potential.
- Foster mutual respect and collaboration.
- Embrace learning, adaptability, and success.
- Recognize the importance of health in our responsibilities.
- Take ownership of solutions and drive results.
Lantheus is an equal opportunity employer, committed to non-discrimination for all employees and qualified applicants, regardless of 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.
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