Life Scientist - Regulatory Operations & Publishing (m/f/d)

Beschreibung

ITM Oncologics GmbH (ITM)


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:

Senior Regulatory Operations & Publishing Manager (f/m/d)

Your Role:

• On regulatory submissions/operations:
  • Administer and Monitor Regulatory Operations systems (e.g. Veeva) and ensure they are being managed properly and working in compliance with existing regulations
  • Work closely with Clinical and CMC Regulatory Affairs, cross-functional teams and relevant vendors to provide operational oversight and support for the planning, preparation, tracking, and timely submission of all regulatory applications and updates to global health authorities (e.g. IND, NDA, MAA, post approval submissions)
  • Plan, execute and track regulatory submissions in timely manner within RIM system including compilation and publishing of electronic regulatory applications, mainly in the eCTD format
  • Serve as the primary point of contact for regulatory publishing activities; ensure all formatting and document completeness
  • Provide guidance and interpret regulations for eCTD publishing and submission formatting, troubleshooting issues related to publishing
  • Identify potential risks to submission plans and propose risk mitigation strategies
  • Report to Regulatory Leads on deliverables for major milestone submissions
  • Represent Regulatory Operations in project teams as a subject matter expert
  • Monitor submission-related global and national health authority regulations and guidelines and adopt filing specifications to ensure compliance with the most current provisions, with a particular focus on FDA, EMA, Health Canada, and ICH
  • Manage use of Regulatory Operations tools (e.g. SharePoint, Adobe, EndNote) for record management and publication
• On Regulatory Information Management (RIM) system:
  • Drive the ongoing set-up of a newly implemented RIM system (including system configuration, data migration, development of best business practices etc.)
  • Provide technical expertise and troubleshooting of technical issues that impact validation requirements within RIM system
  • Archive Health Authority communications and tracking of questions and commitments within Veeva RIM
  • Execute RIM administrator role and coach tool users, as required
  • Maintain and review records and data in the RIM system
• On internal processes:
  • Drive development of internal process documentation including SOPs, work instructions, and best practices on regulatory information system and regulatory publishing topics

What we are looking for:

• Degree in life science; further training in drug regulatory affairs would be a strong plus
• Minimum 5 years of proven practical experience with regulatory publishing and submissions in the eCTD format and within any common regulatory content management system; a strong knowledge of Veeva Vault would be a clear asset
• Advanced knowledge of key regulations, guidelines, and format specifications, at least those of EMA, FDA, and ICH
• Excellent verbal and written communication skills in both, German and English
• Strong interpersonal skills and the ability to work independently, strong service-oriented attitude, team player
• Strong attention to details as well as efficient time management and expressed prioritization skills
• Positive attitude and willingness for further professional development (e.g. take over new responsibilities)

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, diverse corporate benefits and home office possibilities