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25.08.2020


Senior Strategist Clinical Regulatory Affairs (f/m/d)

ITM Oncologics GmbH


ITM Oncologics GmbH is a subsidiary of ITM Isotopen Technologien München AG, a privately held group of companies dedicated to the development, production and global supply of innovative diagnostic and therapeutic radionuclides and radiopharmaceuticals. We are developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing a range of cancers such as neuroendocrine cancers or bone metastases. Our main objectives are to significantly improve outcomes and quality of life for cancer patients while at the same time reducing side-effects and improving health economics through a new generation of Targeted Radionuclide Therapies in Precision Oncology. The headquarters are directly 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:

Senior Strategist Clinical Regulatory Affairs (f/m/d)

Your Role:

  • Develop and implement global regulatory strategies for complex theragnostic radiopharmaceutical products, including proactive identification of regulatory risks / options and mitigation strategies
  • 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
  • Support development of Target Product Profile for assigned development projects
  • Monitor changes in the regulatory environments and advise on company adaptive responses

Your Profile:

  • Successfully completed degree in Live Sciences (for example in Chemistry, Biology, Pharmacy or Medicine)
  • Ideally minimum seven years of regulatory and drug / biologic development experience, ideally in oncology indication; experience with diagnostic radiopharmaceuticals would be an asset
  • Experience in the preparation of regulatory dossiers and submissions to EMA, FDA or other major regulatory authorities
  • Experience in medical writing
  • 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 the development of technologies with a secure future
  • Cross-border intercultural cooperation and short communication channels
  • A collegial corporate culture
  • An attractive salary package and diverse corporate benefits


Applications are accepted either in German or English language.

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?

Send us your detailed CV including earliest start date and salary expectations.

Apply Now

ITM Oncologics GmbH
Human Resources
Walther-von-Dyck-Straße 4
85748 Garching, Germany
E-Mail: career@itm.ag

About ITM Group

ITM Isotopen Technologien München AG 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.

ITM's main objectives are to significicantly improve outcome and quality of life for cancer patients while at the same time reducing side effects and improving health economics through a new generation of Targeted Radionuclide Therapies in Precision Oncology.

Your contact:

Phone: +49 89 329 8986-600
E-Mail: info@itm.ag
www.itm.ag

ITM Isotopen Technologien München AG
Lichtenbergstraße 1
85748 Garching / Munich, Germany

Senior Strategist Clinical Regulatory Affairs (f/m/d) Festanstellung Vollzeit ITM Oncologics GmbH Garching Raum München Bachelor Biologie Chemie Labor Master Medizin Naturwissenschaften Pharmazie Weitere: Sonstige Branchen Biotechnologie,CTA,Pharmazie Festanstellung Vollzeit Mit Berufserfahrung ITM Oncologics GmbH is a subsidiary of ITM Isotopen Technologien München AG, a privately held group of companies dedicated to the development, production and global supply of innovative diagnostic and therapeutic radionuclides and radiopharmaceuticals. 

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