ITM is a privately owned biotechnology and radiopharmaceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for use in cancer treatment. We are developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing cancers such as neuroendocrine cancers or bone metastases. Our main objectives are to significantly improve treatment outcomes and quality of life for cancer patients through a new generation of Targeted Radionuclide Therapies in Precision Oncology. The headquarters are located in the heart of the research center of the Technical University of Munich (TUM).
We would like to fill the following vacancy as soon as possible:
Develop and implement global regulatory strategies for complex theragnostic radiopharmaceutical products, including proactive identification of regulatory risks / options and mitigation strategies
Coordinate with the cross functional teams to fulfill regulatory submissions by assembling, drafting, editing and reviewing
Collaborate with external contractors and consultants in the execution of clinical regulatory activities
Write and/or review of regulatory documents required for filing of NDA / MAAs and IND / CTAs, including but not limited to Modules 2.4 – 2.7, Product Information, responses to the Health Authority questions, clinical study protocols and reports, investigator’s brochures, case report forms, informed consent forms and other relevant documents
Prepare and/or review briefing documents for Health Authority meetings, Orphan Designations Applications and Paediatric Investigation Plans
Contribute to regulatory due diligence of the preclinical and early clinical data in support of early development projects
Providing regulatory intelligence to stakeholders by reviewing and evaluating regulations, guidelines, procedures etc.
Support development of Target Product Profile for assigned development projects
Liaising closely with the Health Authorities and ensuring the optimum relationship between the regulatory authorities and the Company
Monitor changes in the regulatory environments and advise on company adaptive responses
Supporting pricing and reimbursement activities
What we are looking for:
Successfully completed degree in Live Sciences (for example in Chemistry, Biology, Pharmacy or Medicine)
Ideally minimum 5+ years of regulatory and drug / biologic development experience, ideally in oncology indication; experience with diagnostic radiopharmaceuticals would be an asset
Keeping up to date with EU and local legislation, guidelines and practices
Experience in the preparation of regulatory dossiers and submissions to EMA, FDA or other major regulatory authorities. Ideally experience in preparing and submitting New Drug Applications and Marketing Authorisation Applications through Centralized (CP) and Mutual Recognition Procedures (MRP) and National Procedures
Experience in writing of regulatory documents, such as briefing packages for scientific advice meetings, product labels (CCDS, US PI, EU SmPC etc.), response documents, PIP/PSPs etc.
Proven success in global drug regulatory submissions
Leading the regulatory activities from early development to commercial launch
Ability to work in a hierarchically flat matrix environment
Good preclinical and clinical data interpretation / data analysis skills
Good management, interpersonal, communication, negotiation and problem solving skills
Fluent in English, both written and spoken
What we offer:
A modern workplace and exciting opportunities in an evolving and fast growing company
Challenging and varied projects in interdisciplinary, multicultural and highly professional teams
A collegial corporate culture and short communication channels
Flexible working hours with an attractive salary package and diverse corporate benefits
At ITM, we work together towards one common goal – the benefit of our patients. This is what drives us, every day. This is what we are passionate about. For this we create opportunities that are as unique as our team. We encourage diversity and inclusion – the input of our multi-cultural employees makes us who we are.
Only together we can contribute to significantly improving the outcome and quality of life of cancer patients worldwide and to giving better answers than «maybe».
Does this sound like you? Are you interested in shaping the future of ITM and joining one of our highly committed teams in an innovative work environment?
Then send us your detailed CV including earliest start date and salary expectations. The position is intended for the ITM Oncologics GmbH, a company of the ITM group. Applications are accepted either in German or English language.
Contact for your application:
ITM Isotope Technologies Munich SE
85748 Garching / Munich, Germany
Phone: +49 89 3298986-1706
Contact person: Elisabeth von der Grün
For more information please visit: www.itm-radiopharma.com