Your role

On regulatory submissions/operations:

• Administer and Monitor Regulatory Operations systems (e.g. docuBridge, 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

• Assist in planning, execution and tracking of regulatory submissions in timely manner within RIM system including compilation and publishing of electronic regulatory applications, mainly in the eCTD format

• Serve as a point of contact for regulatory publishing activities; ensure all formatting and document completeness

• Report to Regulatory Leads on deliverables for major milestone submissions

• Manage use of Regulatory Operations tools (e.g. SharePoint, Adobe, Acumen Stylus) for record management and publication

• Archive regulatory submission packages within Veeva RIM

• Maintain and review records and data in the RIM system

On Publishing system (docuBridge):

• Compile eCTD submissions according to health authority guidelines and ITM internal standards
• Assist the docuBridge Business Administrator with software maintenance activities, including software updates, data migration, system configuration, and day-to-day business support

On internal processes:

• Support development of internal process documentation including SOPs, work instructions, and best practices on regulatory information system and regulatory publishing topics

Your profile

• Degree in life science; further training in drug regulatory affairs would be a strong plus

• Minimum 3 - 4 years of proven practical experience with regulatory publishing (preferably docuBridge) and submissions in eCTD format and within any common regulatory content management system; a proven knowledge of Veeva Vault would be a clear asset

• Knowledge of key regulations, guidelines, and format specifications, at least those of EMA, FDA, and ICH

• Advanced knowledge in preparing guideline and authority conform submission documents

• Good 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

Nadine Sürken

+49 89 329 8986 -1709

career@itm-radiopharma.com

ITM Isotope Technologies Munich SE
Human Resources
Walther-von-Dyck-Str. 4
85748 Garching/München, Deutschland

With us, you will have the opportunity to work in an international environment on ground-breaking projects that can have a significant impact on cancer care worldwide. We are looking for dedicated, talented and passionate professionals who share our vision and want to help shape the future of oncology. If this exciting challenge appeals to you and you would like to contribute to realising our common goal, please do not hesitate to send us your application. We look forward to hearing from you!