Life Molecular Imaging (LMI) is a global, innovative R &D company focusing on the development and commercialization of molecular imaging radiopharmaceuticals for our approved F-18 amyloid PET tracer Neuraceq® and a pipeline of PET tracers in clinical development. Our vision is to create value for patients and physicians by improving early detection and characterization of chronic and life-threatening diseases leading to better therapeutic outcomes and improved quality of life.

The position will provide regulatory support for the business goals of the company, serving as the US Agent for the US New Drug Application (NDA) holder and will represent LMI as the US Agent before the Food &Drug Administration (FDA). The responsibilities below do not represent the entirety of the role but rather an overview of some of the key tasks. This position will work closely with the team in Germany and must be able to flex time to accommodate other time zones. This position is home-based and must reside in the Eastern or Central Time Zones (does not need to be MA specific)

Key Tasks and Responsibilities:

• Development of regulatory strategy, process management, submission, and procedural management for:
  • New Drug Applications
  • Amendments and Supplements to NDAs
  • INDs
  • Periodic reports
• Creation, review, and approval of labelling specifications
• Review of promotional material for regulatory compliance
• Ensure regulatory and pharmacovigilance compliance: continuous monitoring and analysis of regulatory requirements, e. g. assess impact of upcoming changes, creation and training of regulatory SOPs, maintenance of NDAs and INDs
• Provide regulatory advice on safety reporting questions to development teams and to internal and external collaborators.
• Manage interactions with Competent Authorities (CA), including application, preparation, conduct and follow-up of regulatory meetings, documentation of CA contacts via contact reports.
• Able to travel, including overnights, up to 30% domestically and up to 5% internationally.

What we expect:

To be successful in this role, you must be able to work in a fast-paced, time sensitive critical industry, and have an attention to detail with new and routine tasks. The ideal candidate will have a degree in pharmacy and experience in (a) preparation and labeling text for medicinal products, (b) reviewing promotional materials for compliance, and (c) being the US Agent to government agencies. We are looking for people who are just as passionate as we are to improving the lives of those with Alzheimer’s and other neurodegenerative diseases.

What you can expect:

LMI is seeking candidates who are up for a challenge while being supported by their coworkers, managers, and other divisions of a global company. You will be able to make significant contributions through your expertise. You can expect what YOU do to matter, as all our employees are an integral part of a global organization as well as the communities we serve.

Life Molecular Imaging, Inc. is an Equal Opportunity Employer. We believe what we do and our culture of “It’s More Than a Job. It’s Making Life Better” extends to creating a welcoming, safe, and inclusive work environment. If you have what it takes and the passion to make a difference, please visit our website to learn more. www.life-mi.com