Associate Director, Regulatory Affairs

4 days ago


Bedford, Massachusetts, United States Lantheus Medical Imaging Inc Full time
Job Overview

Lantheus Medical Imaging Inc is a pioneering company in the field of medical imaging, with a rich history of innovation and dedication to enhancing patient care. We are seeking a highly skilled Associate Director, Regulatory Affairs to join our team.

As a key member of our regulatory team, you will be responsible for integrating and applying knowledge of global regulations governing radiopharmaceutical drug development. Your expertise will be crucial in supporting our preclinical/clinical development/commercial programs, including developing regulatory strategy for all phases of drug development.

Key Responsibilities
  • Collaborate with cross-functional teams to provide regulatory guidance and support the preparation, review, and approval of regulatory submissions.
  • Manage concurrent regulatory projects, ensuring timely submission and approval of regulatory documents.
  • Provide current knowledge of regulatory perspectives and considerations to internal functional teams.
  • Serve on cross-functional teams, providing regulatory expertise and making recommendations to ensure compliance.
  • Maintain responsibility for the regulatory strategy related to maintenance of NDA/IND/CTA/IMPD applications and pre-market therapeutic and diagnostic imaging product offerings.
Requirements
  • BS/BA degree in a scientific discipline with a minimum of 5-7+ years of experience in a pharmaceutical industry with a focus on the regulatory perspective related to radiopharmaceuticals.
  • Experience with 21 CFR 212 (i.e. PET Radiopharmaceutical Regulations) is a plus.
  • Veeva RIM experience is a plus.
Core Values
  • Lantheus Medical Imaging Inc 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.


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