Career Opportunity

Global Regulatory Affairs and PV Manager *

Life Molecular Imaging GmbH (LMI) is a German based Research and Development (R&D) organization focused on developing PET imaging solutions to diseases with high unmet medical need. As a division of the Alliance Medical Group, we are a fully integrated pharmaceutical company with research and development laboratories, access to a network of cyclotrons, radiopharmacies and imaging facilities. Our vision is to build our position as an innovator and leading player in the Molecular Imaging field. We aim to create value for patients & physicians by improving early detection and characterization of chronic and life-threatening diseases leading to better therapeutic outcomes and improved quality of life.

The Global Regulatory Affairs & Pharmacovigilance department at Life Molecular Imaging GmbH invites applications for the following full-time position

Global Regulatory Affairs and PV Manager *

The main goal of our company is to develop and market new innovative Positron Emission Tomography (PET)-imaging tracers. It is the task of the Global Regulatory Affairs and Pharma-covigilance (PV) Manager, to

  • Prepare and oversee submission of pre- and post-approval registration dossiers and variations for pharmaceutical products and interact with Health Authorities worldwide
  • Develop and implement approval strategies for investigational medicinal products intended for the worldwide market and for variations
  • Represent Global Regulatory Affairs in international development teams and other teams
  • Ensure regulatory compliance of development and marketed products

You will closely work together with an international and interdisciplinary team of experts in CMC, Preclinical and Clinical Development, Medical Affairs and Pharmacovigilance.

Applicants should have a university degree in natural science, preferably in Pharmacy and experience in Regulatory Affairs or Pharmacovigilance. A solid scientific background and the ability to deal routinely with Microsoft Office is assumed. Applicants should be fluent in English and possess good communication, negotiation, organization and team working skills.

The job location is Berlin, Germany. We offer a competitive salary in an international environment. The position is available from June 2023.

If you want to become part of an entrepreneurial team, if you are prepared to assume a wide range of responsibilities and if your background and personal experience fits this profile, please send us your complete application (cover letter detailing your interest in this position and CV) as a single pdf document to:

Annekathrin Kirchner – jobs@life-mi.com
Life Molecular Imaging GmbH
Tegeler Str. 6-7, 13353 Berlin, Germany

We are looking forward to receiving your detailed application.


* The person counts, not the gender!
Life Molecular Imaging is committed to diversity, rejects discrimination and does not think in categories such as gender, ethnic origin, religion, disability, age or sexual identity.

Life Molecular Imaging GmbH is an Equal Opportunity Employer. We believe what we do and our culture of “More Than a Job. It’s Making Life Better” extends to creating a welcoming, safe, and inclusive work environment.

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

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