Regulatory Affairs Specialist

3 weeks ago


Bedford, Bedford, United Kingdom Lantheus Medical Imaging Inc Full time
Job Title: Regulatory Affairs Specialist

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 Role

We 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
Requirements
  • 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
What We Offer

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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