Global Regulatory Affairs and PV Manager (m/f/d)

Beschreibung

Über uns

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 department at Life Molecular Imaging GmbH invites applications for the following temporary full-time position to cover for pregnancy leave

Main Tasks & Responsibilities

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 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.


Required Qualifications

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.

What we offer

The job location is Berlin, Germany. We offer a competitive salary in an international environment. The position is available from October 2021.

Apply Today

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 as a single pdf document to:

[Click Here to Email Your Resumé]

Frau Annekathrin Kirchner

Life Molecular Imaging GmbH (ehemals Piramal Imaging GmbH)

Tegeler Strasse 6-7
13353 Berlin
life-mi.com

Jetzt bewerben