Regulatory Affairs Specialist
3 weeks ago
Lantheus Medical Imaging Inc is a leading company in the field of medical imaging, with a strong commitment to innovation and patient care. We are seeking an experienced Regulatory Affairs Specialist to join our team.
About the RoleWe are looking for a highly skilled and motivated individual to lead the development and implementation of regulatory strategies for our products. The successful candidate will have a strong background in regulatory affairs, with experience in advertising and promotional materials, labeling, and compliance.
Key Responsibilities- Collaborate with cross-functional teams to develop and implement regulatory strategies for our products
- Lead the preparation and submission of promotional materials to regulatory authorities
- Oversee the maintenance of regulatory labeling for multiple products across therapeutic areas
- Represent the company in regulatory negotiations and meetings
- Monitor and analyze new or revised legislation, regulations, and guidance documents related to promotional communications, disease awareness, and scientific exchange
- PharmD/PhD with 8+ years' relevant experience
- MA/MS/MBA with 12+ years' relevant experience
- Extensive experience leading development of regulatory labeling or related strategies
- Proven track record of successfully managing large-scale, complex, time-sensitive projects
Lantheus Medical Imaging Inc is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
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Regulatory Affairs Specialist
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Bedford, Bedford, United Kingdom Lantheus Medical Imaging Inc Full timeRegulatory Affairs SpecialistLantheus Medical Imaging Inc is a leading company in the field of medical imaging. We are seeking an experienced Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong background in regulatory affairs, with a focus on labeling and promotional communications. The successful candidate will be...
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Regulatory Affairs Specialist
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Bedford, Bedford, United Kingdom Lantheus Medical Imaging Inc Full timeRegulatory Affairs SpecialistLantheus Medical Imaging Inc is a leading company in the field of medical imaging, with a strong commitment to innovation and patient care. We are seeking an experienced Regulatory Affairs Specialist to join our team.Key Responsibilities:Develop and implement regulatory strategies for advertising and promotional materials,...
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Regulatory Affairs Specialist
1 month ago
Bedford, Bedford, United Kingdom Lantheus Medical Imaging Inc Full timeRegulatory Affairs SpecialistLantheus Medical Imaging Inc is a leading company in the field of medical imaging, with a strong commitment to innovation and patient care. We are seeking an experienced Regulatory Affairs Specialist to join our team.Key Responsibilities:Develop and implement regulatory strategies for advertising and promotional materials,...
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Bedford, Bedford, United Kingdom Werfen Full timeJob SummaryThe Principal Regulatory Specialist is a key member of the Regulatory Affairs team at Werfen, responsible for ensuring compliance with regulatory requirements for medical devices and in vitro diagnostics. This role requires a strong understanding of FDA, MDSAP, IVDR, MDR, and international regulations, as well as ISO and other international...
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Regulatory Affairs Specialist
1 month ago
Bedford, Bedford, United Kingdom Werfen Full timeJob SummaryThe Principal Regulatory Specialist is responsible for ensuring compliance with regulatory requirements for medical devices and in vitro diagnostics. This role involves developing and implementing regulatory strategies, preparing regulatory plans and submissions, and collaborating with cross-functional teams to ensure regulatory compliance.Key...
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Senior Regulatory Affairs Specialist
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Bedford, Bedford, United Kingdom Werfen Full timeJob Summary:Werfen is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for our medical devices in China and Japan.Key Responsibilities:Participate in design and risk management teams to provide guidance on...
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