Career Opportunity

Global Regulatory Affairs & Pharmacovigilance – US

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.

Global Regulatory Affairs & Pharmacovigilance - US

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.

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 apply.

Apply here: US Global Regulatory Affairs & PV
Neuraceq® - Product Indications And Use

PRODUCT INDICATIONS AND USE: Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.

Limitations: Limitations of Use
A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. The safety and effectiveness of Neuraceq have not been established for Predicting the development of dementia or other neurologic conditions or monitoring responses to therapies.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS

  • Risk for Image Misinterpretation and other Errors
    Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation [see Clinical Studies (14)]. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.
  • Radiation Risk
    Neuraceq, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration.

ADVERSE REACTIONS:

  • The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/appliucation site erythema (1.7%), injection site irritation (1.1%).

DRUG INTERACTIONS

  • Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Neuraceq image results.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: All radiopharmaceuticals, including Neuraceq, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering Neuraceq administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
  • Lactation: There are no data on the presence of florbetaben F 18 injection in human milk, the effects on the breastfed infant, or the effects of florbetaben F 18 injection on milk production. Exposure of Neuraceq to a breastfed infant can be minimized by temporary discontinuation of breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Neuraceq and any potential adverse effects on the breastfed child from Neuraceq or from the underlying maternal condition.
  • Pediatric Use: Neuraceq is not indicated for use in pediatric patients.
  • Geriatric Use: No overall differences in safety were observed between older and younger subjects

OVERDOSAGE
A pharmacological overdose of Neuraceq is unlikely given the relatively low doses used for diagnostic purposes. In the event of administration of a radiation overdose with Neuraceq, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition. Prior to Neuraceq administration, please read the full Prescribing Information for additional Important Safety Information.

SUSPECTED ADVERSE REACTIONS please report to: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

.
.
.
.
.