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Regulatory Affairs Manager
2 months ago
Lantheus Medical Imaging Inc., a leader in the medical imaging field, is seeking a skilled professional to oversee the development and management of global product labeling components. With a legacy of over 60 years, we are committed to enhancing patient care through innovative diagnostics and therapeutics.
Role Summary
The successful candidate will be accountable for the formulation, upkeep, and execution of comprehensive product labeling strategies, ensuring adherence to global regulatory standards and producing high-quality labeling documentation.
Key Responsibilities
- Lead the Regulatory labeling team in the formulation and upkeep of global product labeling components.
- Collaborate with cross-functional teams, including Supply Chain, Operations, and Clinical, to provide regulatory insights that facilitate the preparation and submission of labeling materials.
- Assess labeling for compliance with regional regulations and provide recommendations to ensure adherence.
- Oversee operations within the labeling management system.
- Act as the primary contact for global product labeling documentation, ensuring compliance with regulatory requirements.
- Support metrics to evaluate the effectiveness of the labeling review process and suggest improvements as necessary.
- Utilize current knowledge of product offerings and industry standards to provide valuable regulatory advice to internal partners.
- Maintain up-to-date knowledge of relevant internal and external systems, technology, and regulatory requirements.
- Promote safety awareness and adherence to safety practices, including the use of protective equipment.
- Propose innovative solutions and strategies, including risk mitigation approaches.
- Evaluate regulatory risks and provide strategic recommendations regarding labeling.
Qualifications
- Bachelor's degree with 4-6 years of regulatory experience in the pharmaceutical sector.
- A minimum of 2 years of experience in Regulatory Labeling.
- Familiarity with advertising, labeling, and promotional regulations for pharmaceuticals and medical devices.
- Willingness to travel as required by business needs.
Core Values
The ideal candidate will embody the core values of Lantheus:
- Empower individuals to achieve their best.
- Foster mutual respect and teamwork.
- Embrace learning, adaptability, and success.
- Recognize the importance of health in our hands.
- Take ownership of solutions and drive results.
Lantheus is dedicated to equal employment opportunities and non-discrimination for all employees and qualified applicants. We are committed to making reasonable accommodations for individuals with known disabilities in accordance with applicable law.
